Riding the Industry Tailwinds
Cautionary Statement
reasonable assumptions, the actual results might differ signi cantly.
Key Economic and Industry Trends
In 2024, the global economy grew at a growth rate of 3.2%. In the past year, the global economy experienced a mix of developments, including moderating inflation, steady growth and rising geopolitical risks. Key events included the continued impact of the war in Ukraine on food and energy supplies, concerns about rising debt and a shift towards soft landing expectations. Central banks began lowering interest rates and the global economy showed resilience despite these challenges.
As we progress through 2025, the landscape has changed as governments around the world have reordered their policy priorities and uncertainties have reached new highs. Forecasts for global growth have been revised markedly down, reflecting effective tariff rates at levels not seen in a century and a highly unpredictable environment. According to the IMFs April 2025 report, global GDP growth is estimated to be 2.8% in 2025 and 3.0% in 2026. Growth in the United States is expected to slow down to 1.8% from 2.8% in 2024. Global headline inflation is expected to decline at a slightly slower pace than what was expected earlier, reaching 4.3% in 2025 and 3.6% in 2026.
In 2024, the Indian economy grew at 6.5% and is projected to grow at 6.2% in 2025 and at 6.3% 2026. The Reserve Bank of India (RBI) has forecasted average inflation to be at 4.0% for FY26. The outlook for Indias external sector remains favourable, with a range-bound currency.
In 2024, the US pharmaceutical market grew to US $487 billion in net price, an increase of 11.4% over the previous year. Total prescription medicine use increased 1.7%, reaching 215 billion days of therapy. A small subset of products drove much of the growth. Thirty-one products had a value greater than US $500 million. These products include GIPGLP-1 agonists, medicines with label expansions and more mature products becoming established in clinical guidelines. Going forward, Oncology and obesity are expected to drive growth through 2029.
Going forward, the global pharmaceutical market is anticipated to expand by 5-8% between 2023 and 2028. The primary factor driving this growth over these ve years is projected to be the availability and utilisation of innovative therapies in developed markets. This growth will be somewhat balanced by losses from patent expirations and the reduced costs of generics and biosimilars. In terms of product type, the original brands are expected to grow in the range of 6-9%, non-original brands at 8-11% and unbranded generics at 3-6%. In terms of geography, developed markets are expected to grow in the range of 5-8%, pharmerging markets at 10-13% and low-income countries at 3-6%.
Key trends shaping the Industry include the enormous success of GLP-1s, a focus in cancer shifting to new modalities like ADCs and Radiopharmaceuticals and Innovator companies looking to mitigate risk against tariffs by relocating manufacturing from Europe to the US.
Key trends shaping the Industry include the enormous success of GLP-1s, a focus in cancer shifting to new modalities like ADCs and Radiopharmaceuticals and Innovator companies looking to mitigate risk against tariffs by relocating manufacturing from Europe to the US.
Novo Nordisks Semaglutide, sold as Ozempic for Type 2 diabetes and Wegovy for obesity, Lillys Tirzepatide, respectively sold as Mounjaro and Zepbound, are the fastest growing drugs in 2025 and are on track to generate more than US $70 billion in sales in 2025.
New modalities are expected to drive oncology spending that include cell and gene therapies, Anti-body Drug Conjugates and radioligand therapies.
In the wake of impending tariffs on Pharmaceuticals, innovator companies are looking to shift manufacturing sites from Europe to the US and also to partner with CDMO companies, which have an on-shore presence in the US. Many large companies, including
Eli Lilly, P zer, Merck and Roche, have announced plans to increase investments in US manufacturing.
Company
Source : 1. 2025 Evaluate Pharma Source : 2. Understanding the use of medicines in the US 2025 by IQVIA Source 3. Radioligand innovators ushering in a new era of precision Oncology - Clarivate
The Advanced Radiopharmaceutical Therapy segment is witnessing the launch of differentiated, high-value products with favourable pharmacological pro les, including lower of target toxicity and higher ef cacy, especially in areas with unmet needs. such as, Pluvicto for Prostate cancer has already achieved sales exceeding US $1 billion. Eli Lillys Kisunla and Eisai Biogens Leqembi have been approved for the treatment of Alzheimers.
M&A activity has also increased, with multiple deals of sizes greater than US $1 billion, marking the entry of big pharma into radiopharmaceutical therapeutics. There are new and emerging isotope pro les with targeted effects and lower off-target impacts, such as Lu177 and Ac225.
The Centre of Medicare and Medicaid Services announced changes to the way it pays for diagnostic radiopharmaceuticals. The agency will separately pay for radiopharmaceuticals above a per day cost of US $630 beginning January 1, 2025.
Jubilant Pharmova Limited is one of the leading players in its addressable market in the US, with a broad pharmaceutical portfolio. The business has an ef cient cost structure with in-house API manufacturing and robust supply chain management. We have an on-shore manufacturing facility in Montreal and Strong R&D capabilities to develop innovative new products. Our Product portfolio is as follows:
Type |
Product | Organ | Key Indication |
PET |
Ruby-Fill ? | Cardiac | Coronary Artery Disease |
Diagnostics |
|||
SPECT |
Tc99m-DTPA | Lung | Pulmonary Embolism |
Diagnostics |
|||
Tc99m-MAA | Lung | Pulmonary Perfusion | |
I-131 | Thyroid | Localising metastases associated | |
with thyroid malignancies | |||
Tc99m- | Cardiac | Cardiac Blood Pool Imaging | |
Gluceptate | |||
Tc99m- | Cardiac | Coronary Artery Disease | |
Sestamibi | |||
Sulfur Colloid | Breast | Localisation of metastatic lymph | |
nodes, imaging of liver, spleen | |||
Tc99m- | Gastrointestinal | Intraabdominal Infection | |
Exametazime | |||
Tc99m- Mertiatide | Renal | Renal failure, Urinary tract obstruction | |
Tc99m-MDP | Musculoskeletal | Delineate areas of altered osteogenesis | |
Therapeutic |
I-131 HICON? | Thyroid | Hyperthyroidism, Selected cases of Carcinoma of Thyroid |
We are market leaders in select products, including MAA, DTPA, Sulphur Colloid and HICON I-131. MAA is used in the perfusion phase of a ventilationperfusion (VQ) scan to diagnose pulmonary embolism. DTPA is used to assess pulmonary ventilation function in association with MAA to perform a Ventilationperfusion (VQ) scan. HICON? I-131 is a radioactive therapeutic agent indicated for the treatment of hyperthyroidism and selected cases of carcinoma of the thyroid.
We are also the innovation leader in the cardiac PET scan market through our product Ruby-Fill?. The market size is roughly US $180 million. And is growing at 12%. The market share of Ruby-Fill? is approximately 25%. The RUBY-FILL? Rubidium 82 generator contains accelerator-produced Strontium-82, which decays to Rubidium-82 (Rb-82). It is used for Cardiac PET scan, a non-invasive imaging procedure of the myocardium, to evaluate regional myocardial perfusion in adults with suspected or existing coronary artery disease. The Ruby-Fill? Cardiac PET franchise delivered a record year with the largest number of new contracts and installations since launch. In FY24, we launched the Rubidium Elution System and Ruby-Fill? (Rubidium Rb82 generator) in mobile settings (Ruby-Fill? Mobile). This allowed us to expand the use of Ruby-Fill? into smaller community hospitals, rural settings and areas with relatively lower volumes but a need for cardiac PET diagnostics. Our focus now is on value engineering to improve margins and increase consistency.
We will be deploying an AI-enabled 3D cardiac blood flow quanti cation system in a short period, which will enable us to deliver an image that previously took 2 hours to produce in under 75 seconds through Arti cial Intelligence.
Through our current product portfolio, we cater to a Total Addressable Market (TAM) of US $400 million. We have a pipeline of new products in SPECT and PET imaging, which will enable us to cater to a new market valued at US $550 million. These new products shall be launched in the market from FY27 onwards.
Timeline |
Incremental TAM | Potential Peak Annual Sales - | No. of Launches |
FY27 |
50 | 20 | 2 |
FY28 |
250 | 60 | 3 |
FY29 |
250 | 40 | 4 |
Total |
550 | 120 | 9 |
Our I131-MIBG program for high-risk Neuroblastoma is making signi cant progress. The dosing of patients in the OPTIMUM Phase II clinical trial was completed in April 2024. We will be sending the data package to the FDA by H2 FY26, followed by a pre-NDA meeting, we will le for approval.We expect to launch MIBG by
FY27 after securing product and manufacturing approvals.
During FY25, radiopharmaceutical revenue grew by 13% YoY to 10,736 million on the back of new product sales in Sulfur colloid and growth in Ruby-Fill?. Reported EBITDA Margin stands at 47% for FY25.
Our vision for Radiopharmaceuticals for FY2030 is to more than double our revenues from FY24 ( 9,518 million ) and reach an EBITDA margin of more than 50%.
Radiopharmacy
Radiopharmacies dispenses and distributes radiopharmaceutical products. The US market is a consolidated market, with the top three radiopharmacy networks dispensing and distributing over 70% of products. One notable transaction that occurred in FY25 is that Telix acquired RLS, the third-largest SPECT radiopharmacy network in the US, for up to US $250 million. This transaction is a testament to the value that radiopharmacy networks bring to the table, providing distribution for radiopharmaceutical players. We believe that it will increase competitive intensity in the radiopharmacy business in the near term while improving the overall market in the medium to long term.
There is an increasing demand for novel PET diagnostics products, which are dispensed through Cyclotron-based PET pharmacies. Additionally, SPECT pharmacies can handle generator-based Ga-68 PSMA-like PET products. We expect pharmacies to increase therapeutics dispensing, driven by stringent USP 825 regulations, as most clinics and hospitals dont want to invest in the clean room infrastructure for dispensing. Additionally, the emerging radioisotope landscape, including Rb-Sr,
Ga-68, Cu-64, Lu-177, Ac-225 and Pb-212, is leading to the development of new PET Imaging and theranostic products, which will further fuel the radiopharmacys share of dispensing and distributing these products.
At Jubilant Pharmova Limited, we operate the second-largest radiopharmacy network, comprising 45 pharmacies (42 SPECT and 3 PET) and cater to over 1,800 hospitals. Our radiopharmacy network is USP 825 compliant and we have 99%+ on-time delivery for our doses. Going forward, we expect Revenue to grow on the back of industry growth and enhance operational ef ciency to increase the EBITDA margin pro le.
In the PET space, we forged pivotal partnerships over the past 24 months for the contract manufacture of leading PET diagnostic products, notably including Life Molecular Imagings F18 Neuraceq and Lantheus F18 Pylarify. In that regard, we are pleased to share that we have started the commercial distribution of PYLARIFY? in FY25, which is an industry-leading prostate cancer diagnostic imaging agent, through two of our PET radiopharmacies. In June 2024, the Company announced an investment of US $50 million to expand its SPECT nuclear pharmacy and PET manufacturing network by adding four (4) SPECT radiopharmacies and six (6) PET manufacturing facilities in strategic locations throughout the United States. The new SPECT pharmacies are expected to open towards the end of FY25 and the start of FY26, whereas the PET manufacturing facilities are scheduled to be operational by the Financial Year 2027-28.
Strengthtened network by adding six PET radiopharmacies.
Expect Asset turnover of 1.0x and RoCE 20%+ on the US 0 million investment.
Given the performance of current PET products and the industry pipeline, PET manufacturing economics is very attractive. In terms of investment, a single PET radiopharmacy investment is approximately US $8 to 10 million. Typically, a PET manufacturing facility can achieve a one-time asset turn and 20% + EBITDA margins.
Apart from that, we also increased our presence for Ga-PSMA across markets, which is a generator-based PET product distributed in SPECT pharmacies.
During FY25, Radiopharmacy Revenue grew by 13% year-over-year (YoY) to 23,144 million, driven by an increase in new product sales. Due to the rise in the competitive intensity in the SPECT radiopharmacy business, shortage of Technitium isotope and several extreme weather-related closures, EBITDA margins lowered to 1% in FY25. Going forward, the increase in PET pharmacy revenues is expected to drive the overall EBITDA margins upward. Our vision for the Radiopharmacy business for
FY2030 is to double our revenues from FY24 ( 20,495 million) and achieve an EBITDA margin of between 7% and 8%.
Allergy Immunotherapy Segment
The global Allergy Immunotherapy market is estimated at US $2.2 billion in 2023 and is expected to grow at a CAGR of 7% to US $3.0 billion by 2028. The Industry is growing on the back of increasing allergy cases, growing awareness of allergy treatment and advancements in treatment options. Allergy immunotherapy (AIT) is a preventive treatment for allergic reactions to a variety of allergens, including pollen, mould, pet dander, food and insects (treated by venom immunotherapy), among others. In this treatment, repeated injections of allergen extracts are administered to develop immunity over a speci ed time period. There are two types of delivery mechanisms: sublingual and Subcutaneous. As per an industry report, more than 50 million Americans suffer from some type of allergy annually.
US Allergy Immunotherapy market is a consolidated market with complex supply chain and grandfathered product approvals, hence being a high-entry barrier market.
Jubilant HollisterStier Allergy is the number two player in the US subcutaneous allergy immunotherapy market and the sole supplier of venom immunotherapy in the US. In addition to the US market, the Company also exports to several international markets, including Canada, Europe and Australia. The product portfolio includes six different insect venom products, over 200 consistent, high-quality allergenic extracts and a range of specialised diagnostic devices for skin testing, backed by best-in-class customer service and high supply reliability. The business is supported by one of the oldest and most trusted brands, HollisterStier, which has been in existence for over 100 years. The business has an on-shore manufacturing facility, which is approved by the US FDA. The business supplies bulk extracts through a dedicated sales team to more than 2,000 allergists and physicians, who then use the products for diagnostic testing and to administer immunotherapy treatment.
The US industry is highly concentrated with well-established players. Raw materials, comprising natural extracts or organisms, involve a complex supply chain from sourcing to processing. New products require biologic license approvals. To succeed, new entrants require a comprehensive portfolio of products, which entails signi cant investment, development and approval lead times.
Venom Extracts |
Allergenic Extracts |
Skin Testing Device |
Venom extracts includes products for Honey Bee, White-Faced Hornet, Yellow |
Allergenic extracts (over 200 products) includes products for Dog, Cat, Mite, |
Multiple Skin test system includes ComforTen, uintest and uintip . |
Hornet, Wasp, Yellow Jacket nad Mixed Vespid allergies. |
Tree Pollen. |
Differentiated product vs. competition |
Sole supplier in US. |
Combination of specialised (e.g., Dog) and standardised extracts (e.g., Cat) 2nd largest |
? stainless steel lancets vs. plastic tips ensuring minimal trauma. |
in the US. |
The business is moving ahead on a three-pronged growth strategy. The rst is to strengthen the existing position in both Venom and non-venom segments in the US. We are increasing customer awareness about the importance of bee sting allergy treatments through targeted marketing campaigns. We are also working to increase Revenue in the US allergenic extract market through an emphasis on science and product differentiation. The second is to expand its footprint in select international markets through strategic partnerships and an expanded distribution channel. Lastly and most importantly, it is essential to develop new products and technologies by increasing investment in R&D. The business continues to develop innovative products to address various allergies, as evidenced by the 2023 launch of Ultra ltered Dog Hair and
Dander extract. This product provides optimal treatment, ensuring dependable, consistent results and ef cacious dosing without precipitate formation.
Strengthen competitive |
Grow outside |
Grow outside |
position in US |
US business |
US business |
Retain and grow Venom customers & patient base. |
Increase outside US Venom sales through strategic partnerships in European markets. |
Develop new products & technologies Build treatment innovation through |
Increase US revenue in Allergenic extracts through targeted marketing. |
partnerships and alliances |
During FY25, Revenue grew by 3%
YoY to 7,013 million on the back of an increase in demand from the US market. EBITDA margin for the year stands at 35%. During the year, the margin decreased year-over-year (YoY) due to weakness in exports and production challenges for speci c stock-keeping units (SKUs). Production challenges have been solved and normalised production has resumed. We anticipate outside US sales to gradually improve. Our vision for the Allergy Immunotherapy business for FY30 is to grow revenues by one and a half times FY24 ( 6,786 million ) and maintain an EBITDA margin between 35 and 40%.
Vial lling
Year | 2023 | 2024 | 2025 | 2026 | 2027 |
Demand | 4.9 | 5.2 | 5.7 | 6.2 | 6.8 |
Supply | 5.5 | 5.8 | 6.1 | 6.1 | 6.1 |
The global Sterile Injectables market is estimated to grow from US $13 billion in 2023 to US $20 billion in 2027. The demand is primarily driven by the increase in the development pipeline for biologics, predominantly in vial format and the rise in loss of exclusivity. Since 2015, injectables have made up a large number of new drug shortages. Estimates predict a demand supply gap of 700 million vials by 2027 according to a recent McKinsey study, which may be further widened by industry consolidation of manufacturing facilities.
Structural demand drivers are further influencing the need for more North American manufacturing capacity. It takes a large, upfront capital expenditure to build a new pharma manufacturing facility. Leading pharma companies are focusing their limited internal capacity on highly specialised products from their portfolio and are looking to external partners for cost-effective ways to produce their other drug products. Once a pharma company has chosen a contract manufacturing partner, it can take a considerable amount of time and extra costs to switch to a different contract manufacturer. As a result, pharma companies often enter long contract periods with auto renewals in place with their manufacturing partners.
Additionally, in response to geopolitical shifts and tariff uncertainty, global pharma companies are exploring US - based production to better serve domestic patients while reducing costs and supply chain risks. The regulatory advantages and quality of North American manufactured products are a further draw for innovator pharma companies.
registrations achieved for our facilities, approved by global regulators including US FDA, Health Canada, ANVISA Brazil, PMDA Japan and MHRA UK.
Jubilant Pharmova Limited provides comprehensive sterile ll- nish, ophthalmic and lyophilization services, ensuring the consistent delivery of high-quality products that meet the needs of global healthcare markets and patients worldwide.
With decades of experience and our dual sites in Spokane and Montreal, we offer a flexible and collaborative partnership model for manufacturing excellence that enables our clients to increase speed to market with full regulatory con dence.
Our top 10 customers have partnered with us for over 5 years, demonstrating the success of our long-term customer relationships. Trusted by 5 of the top 20 global pharma companies as partners, we have a 92% customer retention rate that reflects our high level of customer satisfaction. We also have a proven track record with regulatory organisations like the FDA, EMA, PMDA Japan, Health Canada, ANVISA Brazil and other bodies in over 140 countries worldwide. A strong focus on compliance and quality alongside a lean operational setup is instrumental to the growth of our business.
In February 2024 we opened our third line, marking the completion of the rst half of our state-of-the-art expansion project that will double our capacity. This expansion is partly funded through the cooperative agreement of US $149.6 million that the Companys subsidiary
Jubilant Hollisterstier LLC entered into with the Army Contracting Command, in coordination with the Joint Program Executive Of ce for Chemical, Biological,
Radiological and Nuclear Defence (JPEOCBRND) on behalf of Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. This initiative is focused on modernising our facilities to meet current and future production demands and is currently on track with respect to time and cost. Tech transfer plans for customers moving products to Line 3 are currently in progress. Line 3 successfully completed its rst product quali cation batches and media lls and commercial production is expected to start after FDA approval in late FY26.
We are currently constructing our fourth high-speed injectable-liquid lling line, which will be operational by late FY28. A key component of this modernisation is the integration of advanced isolator technology, which will signi cantly enhance our facilitys aseptic processing capabilities and ensure compliance with the highest standards of sterility and safety. The expansion is not only increasing physical capacity but also transforming operational capabilities. The 160,000 sq. ft. expansion and the addition of multiple 350 ft2 + lyophilizers will further increase capacity.
The line 4 expansion also include additional operational space with a build-out, loading docks, ultra-cold storage and temperature-controlled capabilities, a high-speed packaging line, environmental monitoring, stability space and a new employee services area. By upgrading infrastructure and implementing cutting-edge technologies, we are positioned to ef ciently support the production of additional medicines. This approach leverages existing assets while aligning with long-term strategic goals for scalability and innovation in pharmaceutical manufacturing.
The combined revenue potential for Lines 3 and 4 is estimated at US $160 to US $180 million. On average, it takes four years post-commercialisation to reach optimal capacity. However, due to US market shortages, we plan to ll the new capacity in about 3 years. Furthermore, we anticipate higher-than-average EBITDA margins on revenue driven by lines 3 and 4 because of the improved pricing structure available for access to highly innovative production lines and lower overhead costs.
In Montreal, we announced an investment of US $114 million to expand Canadian operations. The Canadian government is helping fund approximately US $40Mn of the project cost through partially repayable loans and other methods. We are also investing in ophthalmic solutions with the construction of a 200-bottle-per-minute
lling line that is currently in the validation process. We are on track for commercial validation by the end of FY26.
The Montreal facility received an OAI classi cation following an FDA audit in FY25.
In response to the FDA audit observations and updated cGMP guidelines, we implemented Corrective and Preventive Actions (CAPAs). After completing the
CAPAs, the Montreal facility successfully restarted sterile ll- nish production.
Ophthalmic line production is expected to resume in H2 FY26.
During FY25, CDMO Sterile Injectables revenue grew by 14% year-over-year (YoY) to 12,717 million and Reported EBITDA grew by 52% YoY to 2,919 million. Our vision for the CDMO Sterile Injectables business for FY30 is to more than double our revenues from FY24 ( 11,171 million) and reach an EBITDA margin of more than 25%.
Commercial Excellence & Customer Satisfaction
In FY25, we deployed a new commercial model focused on expanding our customer base and product portfolio. By developing key account and business development verticals, the key account team can focus on farming additional business from existing customers while business development can hunt for new customers. Considering the top 10 current customers who have worked with us for over 5 years and 92% of customers do repeat business with us, our customer retention rate indicates a high level of customer satisfaction. Since we have partnerships in place with 5 of the top 20 global pharma companies, there are ample opportunities for both farming and hunting with pharma companies of all sizes. The success of this strategy has secured multiple new customers and new product wins across existing lines and for the Line 3 expansion.
We have accelerated the commercial timeline for Line 3 and initiated multiple customers through the tech transfer process for various New Product Introductions (NPIs). We demonstrated our ability to speed up the commercial timeline for NPIs during the COVID-19 pandemic, when multiple therapeutics transferred over in less than six months. With project management as a core competency, our strong bench of experienced professionals leads the tech transfer process and manages regulatory approvals. Many employees bring years of floor experience alongside their project management skills, making them highly effective and knowledgeable across the entire product life cycle and in their ability to collaborate across departments. Lastly, our focus on Commercial Excellence and revamping our entire Commercial Strategy and resources are evident in our website containing further information along with videos educational information supporting our services: www.jublhs.com
Contract Research Development and Manufacturing Organisation (CRDMO) Segment
Our CRDMO segment includes drug discovery services and CDMO-API business. In FY25, Revenue grew by 5% to 11,510 million. EBITDA grew by 32% to 2,238 million, respectively.
Drug Discovery Services
The global drug discovery market is expected to grow from US $8 billion to US $10 billion by 2028, driven by the rise in specialised technologies such as Antibody-Drug Conjugates and Oligonucleotides. We are bullish on the mid and long-term prospects of the CRO industry in India, given talent availability & gradual shifting of demand due to the preference for friend sourcing locations due to Biosecure ACT. Over the last two years, we have been expanding our partnership with large Pharmaceutical companies, leveraging our infrastructure, capacity and capabilities. We expect revenue growth to continue, driven by our large pharma strategy and favourable industry tailwinds.
We are a leading Indian Contract Research, Development and Manufacturing Organisation (CRDMO) with strong customer relationships. We serve eight of the top 20 pharma companies with a 5x increase in revenue contribution from large pharma in the last year. We are a partner of choice for Integrated Drug Discovery in India, with a track record of 85-plus programs. We are a fully integrated Chemistry services powerhouse from mg to multi-ton scale production. We have successfully scaled up CDMO services for Biotech and Large Pharma across the product life cycle.
In our Drug Discovery Services business, we focus on offering integrated solutions to our customers, which maximises the speed to develop a new lead. Our service offering includes early Drug Discovery Services, ranging from milligram to kilogram non-GMP and GMP scale-up of novel compounds, intermediates and New Chemical Entities (NCEs). In FY25, our portfolio of projects encompassed Full-Time Equivalent (FTE), Fee-for-Service (FFS) and Integrated Drug Discovery (IDD) contracts. The business operates seamlessly across Bengaluru, Noida and Greater Noida sites in India, offering integrated as well as functional drug discovery services and development services to global innovators. Our therapeutic areas of expertise include Oncology, Metabolic Disorders, Central Nervous System (CNS) disorders, Pain and Inflammation.
Our revenues grew by a double-digit percentage in FY25 as we began onboarding large pharmaceutical customers. We expect to scale up existing large pharma customers while continuing to add other marquee large pharma and biotech companies as customers. The impact of the BioSecure Act has prompted US pharma companies to seek alternatives to China. This could act as a catalyst for India to attract more business in due course of time. In the last year, we onboarded three large pharmaceutical companies as our clients. We have increased our revenue share from large pharma from less than 5% in FY23 to approx. 25% in FY25.
We are well-prepared to scale up our infrastructure and scienti c talent further to take advantage of the upcoming CRO demand. Adding capacity at our current sites in Greater Noida and Bengaluru can support a doubling of revenues. Additionally, we are building another flagship drug discovery site in Devanahalli, Bengaluru, which will support quadrupling of our revenues. The estimated capital expenditure (Capex) is approximately US $150 million and we expect a Return on Capital Expenditure (RoCE) of greater than 20% on this Capex.
FY25 has been an year of transformation with addition of three large pharma customers, strategic partnership with Pierre Fabre in Europe which in turn added capabilities in areas like Biologics and ADCs.
Earlier this year, we announced a transaction agreement with Pierre Fabre, France. This transaction agreement will enable Jubilant Biosys Limited to acquire the former Centre of Immunology as Jubilant Biosys France, with a majority stake, thereby expanding its footprint in Europe in areas such as biologics (mAbs) and Antibody Drug Conjugates (ADC), in addition to its existing services, including integrated drug discovery services from India.
We also offer a Cloud/SaaS (Software as a Service) solution based on our Arti cial
IntelligenceMachine Learning proprietary platform for clinical trials. The eClinical suite includes TrialStat? Orbit for electronic database capture, TrialStat? CTMS for Clinical Trial Management Software and TrialStat Portal for analytics and customer interface software.
During FY25, drug discovery services revenue increased by 27% year-over-year
(YoY) to 5,699 million and Reported EBITDA grew by 29% YoY to 1,364 million.
Our vision for the drug discovery services business for FY30 is to triple our revenues from FY24 ( 4,485 million ) and reach an EBITDA margin of more than 25%.
APIs, also known as Active Pharmaceutical Ingredients, are responsible for rendering the therapeutic action to the nal formulation of a drug.
Growth drivers for the API market include a rise in chronic diseases and the geriatric population, favourable government policies for API production, an increase in R&D expenditures and advancements in API manufacturing. Other factors encouraging market expansion include the growth of the small molecule segment, rising API complexity, companies desire to reduce costs and the rapid expansion of outsourcing services in the pharmaceutical sector.
The CDMO API market is also expected to grow from US $95 billion to US $130 billion by 2028, supporting the increasing number of clinical trials and the rise of integrated and specialised CDMO services. Although small molecules dominate the CDMO API market, higher growth is expected in segments such as high-potency APIs and large molecules. The Industry is increasing backward integration to mitigate the pricing pressure. The move towards friend sourcing is also becoming increasingly apparent, thereby reducing the concentration risk of generics API manufacturing.
Our Company offers a broad portfolio comprising approximately 100 different APIs from various therapeutic categories, including the Central Nervous System (CNS), Cardiovascular System (CVS), anti-infectives and anti-diabetics. We are leaders in Carbamazepine, Oxcarbazepine and
Pinaverium. We have a diversi ed and large external customer base (over 160 customers) with a reach spanning more than 50 countries.
We have a state-of-the-art manufacturing facility in Nanjangud, India, spanning over 41 acres with eight multi-stream manufacturing blocks. In March 2023, we received the Voluntary
Action Indicated (VAI) classi cation from the US Food and Drug Administration (FDA) for this facility.
We have the following three focus areas in CDMO API. The rst is to launch new generic APIs. Our new product development philosophy is innovation-led affordability and quality-by-design, which gives our customers access to cost-effective APIs while maintaining consistent global quality standards. Aided by strong process and analytical chemistry capabilities, as well as IP and regulatory expertise, we will continue to focus on developing new products and lings for key markets. The second focus area is the large-scale custom manufacturing of APIs, where we aim to partner with major pharmaceutical innovator companies to manufacture products that require life cycle management. The third focus area is to scale up operations in early Phase CDMO for our drug discovery customers who are progressing through our drug discovery cycle. We want to leverage our GMP manufacturing capabilities for Innovative APIs, particularly as they progress from our discovery services pipeline.
We have ongoing initiatives to reduce costs by continuously streamlining our operations, enhancing yield, refocusing on R&D, onboarding alternative vendors, derisking our operations and supply chain and optimising input material costs. This will help us maintain pro tability and maintain market share despite increasing competition and pricing pressure.
According to estimates, 70% of Indias API requirement is met through China. We are aggressively working to reduce our dependence on China for raw materials by ramping up domestic capacity and developing reliable local vendors for sustainability and quality. For the critical APIs, the Company aims to secure the entire value chain through backward integration. In this context, we have already started producing multiple Key Starting Materials (KSMs) in India using in-house technologies. We are developing an action plan for implementation of continuous manufacturing or flow chemistry for the KSMs.
For the CDMO API in FY25, the Revenue stands at 5,811 million. EBITDA grew by 39% to 874 million. EBITDA margins expanded on a YoY basis due to cost optimisation efforts through structural cost reduction. Going forward, we expect signi cantly improved performance in terms of revenue growth, driven by increased capacity utilisation and expansion of the EBITDA margin. Our vision for the API business in FY30 is to double our revenues from FY24
( 6,445 million) and achieve an EBITDA margin of more than 15%.
The global Generics market is estimated to grow from US $406 billion in 2023 to US $532 billion in 2028, driven by the rise in chronic disease prevalence and the expiration of exclusivity for innovator products. Notably, the US market is expected to grow at approximately 2%, with signs of price reductions in line with historical trends. The non-US international market is expected to grow in the 5% to 7% range across different markets and the Indian market is anticipated to grow largely in 8-12% range.
Our Generics business includes the development, manufacturing, distribution, sales and marketing of generics formulations. The broad therapeutic areas covered include the Cardiovascular System (CVS), Central Nervous System (CNS), Gastrointestinal (GI) tract, antibiotics and multi-speciality (MS) areas. We have a global presence and serve more than 50 countries, including the US, UK, Europe, Canada,
Japan, Australia, South Africa and UAE. We are building a branded generics business in India, focusing on the elds of cardiovascular and diabetes care. We have a manufacturing facility for generics in Roorkee and we are also developing a network of globally available contract manufacturers (arrangements in place with more than ve) to establish cost-effective manufacturing facilities and de-risk product supplies. Various regulatory agencies of different countries have approved our Roorkee facility, including the US FDA, Federal Agency for Medicines and Health Products (FAMHP) Belgium, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, Therapeutic Goods Administration (TGA) Australia, MHRA UK, South African Health Products Regulatory Authority (SAHPRA) etc.
Our growth strategy for key markets is outlined below
Over the last few years, the US Generics market has been witnessing signi cant pricing pressure, led by demand-supply imbalances, consolidation in the drug buyer market and vertical integration of GPOs with large retail pharmacy chains. Our US
Generics company had been experiencing signi cant losses since FY22 due to the high cost of manufacturing in the US, combined with low drug prices. To move the US generics business to pro tability, it was decided to close the in-house manufacturing operations at the US manufacturing facility, which has been completed in Q1 FY25.
We transferred the pro table products to CMOs and the supply has been started from CMOs to the US market. We will continue to maintain a sales & marketing presence in the US, marketing supplies from our US FDA-approved Roorkee facility in India, as well as new CMOs and products through the in-licensing route. These actions have improved the business gross margins and it has achieved pro tability in FY25. Furthermore, the in-licensing of new products will not only expand the Companys revenue base but also ensure a robust product portfolio.
On the non-US international market side, the UK remains a key growth market, where we have established our subsidiary and maintain a on-the-ground direct presence. We are also further strengthening our team and product portfolio to harness the UK market through this subsidiary. We have import approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for 23 products as of March 25. Similarly, we have our on-the-ground direct presence, established through our subsidiary in the UAE, which will focus on expanding operations in the Middle East as part of our growth plan. We plan to build in three to four key markets, such as the UK and UAE. Beyond establishing an in-market presence, we are also offering top 10 products across 50+ markets. We plan to grow the revenue base by introducing new products through In-Licensing, in addition to commercialising existing products in additional markets.
We are building a branded Generics business in India. India has been small for us so far, but over the last two years, we have seen good growth from a small base. We are focused on four indications today: a combination of cardio-diabetic conditions, including Dyslipidemia, Hypertension and Diabetes. We have also introduced a product in weight management, which has seen a good early pick-up and we expect to grow over the next several quarters. We will continue to invest and grow the India business at 1.5 times faster than the Industry.
Our Operations strategy is focused on continuous Quality improvement, derisking product supplies by building a global CMO network and continuous cost optimisation.
Our Roorkee facility received an Import Alert in July 2021, followed by an inspection in July 2022, which concluded with the same status: Of cial Action Indicated classi cation, by the US
FDA on October 22. The US FDA further audited the Roorkee facility in February 2024 and this audit was concluded successfully with a Voluntary Action Indicated for the Roorkee facility. We are increasing the exports from the Roorkee facility to the US in a meaningful and gradual manner.
For FY25, Generics Revenue stands at
6,853 million. We consciously focused on pro table products, which resulted in lower revenues compared to last year. Reported EBITDA grew from negative
1,408 million to positive 236 million.
Our vision for Generics business for FY30 is to double our revenues from
FY24 ( 7,746 million ) and reach
EBITDA margin in the range of 15% to 17%.
6-8
New Products
Launches in US and non-Us International markets every year
Proprietary Novel Drugs Segment
Jubilant Therapeutics is a clinical-stage precision therapeutics company advancing potent and selective small molecule modulators to address unmet medical needs in oncology and autoimmune diseases. The Company is focused on speci c set of patients who are either not responding to other therapies or for whom there are no effective treatment options available. It has a low-cost in-house drug discovery engine. Within a few years of its inception, the Company has had many successes to its credit. Two of the programs have received US FDA clearance for IND ling for clinical trials.
The drug discovery platform is validated with partnering in two of the programs. One of the partnered programs was acquired by Blueprint Medicines (NASDAQ: BPMC), a formidable biotech and has proceeded to Phase I. The Company has received orphan drug designations from the US FDA for multiple indications in the programs, which allows it to avail various incentives, including accelerated FDA reviews, several cost-saving bene ts and market exclusivity upon launch.
The Companys key strengths include:
State-of-the-art discovery engine to make easy-to-use oral drugs for dif cult-to-treat cancers and autoimmune disease.
Differentiated pipeline and platform.
Experienced leadership and globally renowned advisory board members.
Track record of premier research collaborations, including with Memorial Sloan Kettering, Boston Childrens Hospital, Wistar Institute, Tel Aviv University and Cedar Sinai.
Publications and presentations in world-class scienti c conferences such as ASCO, AACR and peer-reviewed journals such as Nature Scienti c Reports.
Key Programs:
The Companys most advanced program (CoREST inhibitor), JBI-802 Phase 1 clinical data established safety and further, dose-dependent platelet effect was seen in the clinic at higher doses, establishing application in Essential Thrombocythemia (ET) and other Myeloproliferative Neoplasms (MPNs). In light of these ndings, we have initiated a Phase II clinical trial to treat ET and MPN patients with Thrombocytosis (high platelet counts).
The Phase I trial also demonstrated anti-tumour response in two lung cancer patients with a good safety pro le. One non-small cell lung cancer (NSCLC) patient with
STK11 mutations, having progressed on prior doublet immune-oncology (IO) therapy, showed a con rmed partial response (tumour reduction). Generally, the survival rate is very low in such cases. However, the patient has responded well to JBI-802 monotherapy, with a meaningful improvement in quality of life and has continued treatment with our novel oral pills for over a year. Therefore, a larger investigator-led clinical trial in NSCLC is being initiated at Christ Hospital in Ohio, USA. The Company is also in discussions with Memorial Sloan Kettering for an investigator-led trial in post-MPN AML (Erythroleukemia).
The second program (PRMT5 inhibitor) is JBI-778, which is the next generation, small molecule, orally available and brain penetrant oral pill for select cancers. We have now launched Phase I, the rst human study for this molecule, in patients with speci c cancer subtypes at major oncology centres in India.
Program |
Mechanism | Indications | Lead Optimisation | Pre - Clinical (IND) | Phase I / II | Milestones |
JBI-802 |
coREST Inhibitor | ET (Essential Thrombocythemia) | Phase I data suggest | |||
Epigenetic Modulating Agent | MPN (Myeloproliferative neoplasms), NSCLC (Non-small Cell Lung Cancer) | therapeutic potential. First Patient dosing done.Interim Phase II data in 2025 | ||||
JBI-778 |
PRMT5 Inhibitor Brain Penetrant | EGFR (Epidemal Growth Factor Receptor) refractory NSCLC, ACC (Adenoid Cystic Carcinoma), High | Phase I trial under progress | |||
Grade Giloma | First Patient dosing done.Interim Phase I data in 2025 | |||||
JBI-2174 |
PD-L1 Inhibitor Brain Penetrant | Brain tumor and metastases | IND enabling | |||
JBI-1044 Other |
PAD4 Inhibitor Various | Oncology and Auto-immune disease Various | IND enabling Undisclosed Research Programs |
We shall look to pursue Phase 2 trials for JBI-802, along with a Phase I study for JBI-778. We will then use the emerging data as a catalyst for raising capital through either institutional funding or strategic partnerships. Our drugs under development have the potential to address high unmet medical needs globally, with a multi-billion-dollar market size. The space in which we operate is marked by a handful of peer companies that have commanded signi cant intrinsic value in recent transactions.
Revenue
Revenue during the year was 72,345 million as compared to 67,029 million in FY24. Total income during the year was 72,913 million as compared to 67,716 million in FY24.
FY25 Revenue grew by 8% on the back of growth in revenue across Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables and
CRDMO. Revenue from the Radiopharma segment was at 33,880 million vs. 30,013 million in FY24 and contributed 47% to overall Revenue. For Allergy Immunotherapy, the Revenue was 7,013 million, compared to 6,786 million in the previous year, representing 10% of the total Revenue. Revenue from the
CDMO Sterile Injectables segment was at 12,717 million vs. 11,171 million in FY24 and contributed 18% to overall Revenue. Revenue from the CRDMO segment was at 11,510 million vs. 10,930 million in FY24 and contributed 16% to overall Revenue.For Generics, the Revenue was 6,853 million, compared to 7,746 million in the previous year, representing 9% of the total Revenue.
Expenditure
Expenditure for operations was at 60,608 million in FY25 as compared to 58,021 million in the previous year. Material cost and change in inventory stood at 20,199 million vs. 18,995 million in FY24. Employee bene ts expense in FY25 was 22,679 million. Other expenses in FY25 were 14,759 million.
Earnings Before Interest, Taxes, Depreciation and Amortisation (EBITDA)
The Reported EBITDA from operations was 12,300 million in FY25 as compared to 9,936 million in the previous year. FY25 EBITDA Margins expanded by 220 basis points to 16.9% due to improved performance in CDMO Sterile Injectables, CRDMO and Generics.
EBITDA from the Radiopharma segment was 5,351 million vs. 5,840 million in FY24.
For Allergy Immunotherapy, the EBITDA was 2,451 million vs. 2,734 million in the previous year.
EBITDA from the CDMO Sterile Injectables segment was 2,919 million vs. 1,923 million in the previous year.
EBITDA from the CRDMO segment was 2,238 million vs. 1,692 million in FY24.
For Generics, the EBITDA was 236 million vs. -ve 1,408 million in the previous year.
Finance Cost and Depreciation
Depreciation and amortisation was 3,686 million in FY25, compared to 3,819 million in FY24. The nance cost was 2,403 million as compared to 2,723 million in FY24.
Pro t Before Tax
Pro t before Tax was 9,806 million as compared to 1,705 million in FY24.
Tax Expenses
Tax expenses were 1,443 million in FY25 as compared to 978 million in the previous year.
Pro t After Tax
Pro t after Tax was 8,363 million, compared to 727 million in the previous year. Basic Earnings per Share (EPS) was at 52.99 vs 4.87 in FY24. Normalised Pro t after Tax was 4,152 million in FY25, compared to 1,955 million in FY24. FY25 Normalised PAT increased by 112% due to improved operating performance and reduction in
nance cost.
Segment Revenue |
||||
Particulars |
FY24 | FY25 | YoY Growth | Revenue Mix FY2025 |
Million | Million | % | % | |
Radiopharma | 30,013 | 33,880 | 13% | 47% |
Radiopharmaceuticals | 9,518 | 10,736 | 13% | 15% |
Radiopharmacies | 20,495 | 23,144 | 13% | 32% |
Allergy immunotherapy | 6,786 | 7,013 | 3% | 10% |
CDMO Sterile lnjectables | 11,171 | 12,717 | 14% | 18% |
Contract Research, Development and | 10,930 | 11,510 | 5% | 16% |
Manufacturing Organisation | ||||
Drug Discovery Services | 4,485 | 5,699 | 27% | 8% |
CDMO - API | 6,445 | 5,811 | -10% | 8% |
Generics | 7,746 | 6,853 | -12% | 9% |
Proprietary Novel Drugs | 0 | 0 | 0% | |
Unallocable Corporate Income | 383 | 372 | ||
Total Revenue |
67,029 | 72,345 |
Segment EBITDA |
|||
Particulars |
FY24 | FY25 | YoY Growth |
Million | Million | (%) | |
Radiopharma | 5,840 | 5,351 | -8% |
Radiopharmaceuticals | 4,775 | 5,053 | 6% |
Radiopharmacies | 555 | 298 | -46% |
Allergy lmmunotherapy | 2,734 | 2,451 | -10% |
CDMO Sterile lnjectables | 1,923 | 2,919 | 52% |
Contract Research, Development and Manufacturing Organisation | 1,692 | 2,238 | 32% |
Drug Discovery Services | 1,061 | 1,364 | 29% |
CDMO - API | 631 | 874 | 39% |
Generics | (1,408) | 236 | 117% |
Proprietary Novel Drugs | (299) | (178) | 40% |
Unallocable Corporate (Expenses) Income | (546) | (717) | |
Total EBITDA |
9,936 | 12,300 |
Note: In FY24, Radiopharma segment EBITDA includes EBITDA share and share of Pro t from So e at 510 million *EBITDA includes other income and share of pro t/(loss) from As
Key Ratios
Particulars |
Units | FY24 | FY25 |
Debtor Turnover | times | 7.3 | 8.1 |
Inventory Turnover | times | 1.6 | 1.9 |
Payable Turnover | times | 2.4 | 2.2 |
Cash Conversion Cycle | days | 128 | 66 |
Interest Coverage | times | 3.6 | 5.1 |
Current Ratio | times | 2.1 | 1.7 |
Debt Equity Ratio | times | 0.5 | 0.2 |
Operating Pro t Margin | % | 14% | 16% |
Net Pro t Margin | % | 1% | 12% |
Return on Net Worth | % | 1% | 13% |
Net Pro t Margin and Return on net worth were impacted by exceptional income of 3,595 million in FY25. Adjusted for this income, Net Pro t Margin and Return on Net Worth stand at 6% and 7%, respectively.
Business Enablers
Research & Development and Intellectual Property
Our Research & Development (R&D) is an ever-evolving centre of excellence, remaining committed to its belief in innovation and quality, which helps magnify the Companys business aspirations.
The focus of our R&D is to enhance innovation, scienti c ef ciency and effectiveness in compliance with Jubilant Pharmova Limiteds core values and support the execution of business strategies. Our R&D continues to lead to new, innovative processes and knowledge-driven products that increase the ef ciencies of our production and allow us to capitalise on opportunities for growth in competitive markets.
The multi-skilled R&D teams, with specialisation across the pharmaceutical value chain, focus on research into novel drug delivery systems, radiopharmaceuticals, allergenic extracts, analytical research and biological support, including clinical studies. R&D supports the activities of our various businesses by developing breakthrough technologies in new products, process chemistry, analytical chemistry, process intensi cation and establishing these technologies at a commercial scale.
All the R&D centres are process-driven and promote a disciplined work culture. Our strong internal audit framework ensures overall regulatory compliance. The R&D team stays up-to-date with regulations and emerging technological trends, proactively ensuring pharmacopeial compliance while adopting best industry practices.
Our Intellectual Property (IP)-enabled, innovative R&D efforts helped us avoid IP disputes by developing outstanding design capabilities by identifying newer opportunities, gaining a better understanding of emerging challenges, developing alternative innovative research strategies and creating intellectual property that is well-protected in the geographies of our business interests. Our efforts have yielded intellectual properties, which have grown over the years, establishing a strong position for the generic pharmaceutical business in regulated markets. We protect our inventions by ling patent applications in India, the US, Europe, Canada, Australia, China and other countries, including International Patent Cooperation Treaty (PCT) applications.
Our Radiopharmaceuticals business has a focused R&D team with radiochemistry expertise, based in Montreal, Canada. We also have a support team in India and the USA. The R&D team works on nuclear medicine for the diagnosis, treatment and monitoring of various diseases, as well as cancer treatment using radiopharmaceutical agents. It serves hospital-based customers (nuclear medicine physicians and technologists) and radiopharmacies, globally, with high-quality and reliable speciality products. The business is backed by a dedicated R&D team, specialising in drug discovery, product development, analytical chemistry, radiochemistry, animal testing, manufacturing, strong regulatory and medical affairs and commercial operations, all utilising radiation safety protocols. The areas of specialisation include cardiac, lung, bone and thyroid diseases. This team supports existing products and leads the development of new products.
We are continually engaged in the development of new products, that have yielded a pipeline of products that will be introduced in future. We are striving to enhance our product offerings across diagnostics and therapeutics, increasing the bandwidth of products and their applications. The team also had a strong device team consisting of electrical engineers, mechanical engineers, system engineers and component engineers. The R&D group is also developing arti cial intelligence-based software solutions for enhanced imaging.
Currently, the team is working on multiple diagnostic agents that will be targeted for approval in the next three years. The R&D team is also working on at least one therapeutic product called I-131MIBG (MIBG). MIBG is currently undergoing a clinical trial and we are expecting to le it in the near future. We expect to le an AI-based imaging enhancement for our Ruby-Fill? system this year, along with at least one additional SPECT product.
Allergy R&D has expertise in biopharmaceuticals speci cally sterile liquid vaccines.
The core focus is on allergen (natural) extracts for immunotherapy with a range of vaccines to immunise patients against lgE-mediated allergen-speci c hypersensitivity.
Its cGMP facility manufactures products to meet the high-quality standards followed in the allergy industry. Over the years, the Company has expanded its customer base to include allergists, ENT doctors and clinics, hospitals and pharmacies, across the US, Canada, Australia and other international markets.
Till date, in the Generics business, we have led a total of 101 Abbreviated New Drug
Applications (ANDAs) in the US, 30 dossiers in Europe, 29 in the UK, 25 in Canada and 47 in other Rest of the World (RoW) countries. We have received 70 approvals in the US, 23 in the UK, 29 in Europe, 24 in Canada and 43 in the RoW markets. We have an objective of launching six to eight products a year in our key focus markets, the UK and UAE, either through our in-house pipeline or through an in-licensing route. Additionally, we continue to make efforts to launch or relaunch six to eight products annually in the US market, either through in-licensing or at Roorkee or additional contract manufacturing sites.
The Drug Discovery Services business offers state-of-the-art capabilities in small molecule discovery and preclinical development. These include capabilities in Discovery Informatics, Molecular Modelling, Structural Biology, Medicinal Chemistry, Synthetic Chemistry, in vitro Biology, in vivo Biology, DMPK studies, Pharmacology, Toxicology, Scale-up and GMP. Our disease biology expertise spans across multiple therapy areas, including oncology, metabolic disorders, neurological disorders and inflammation.
The passion of our scientists drives Drug Discovery, providing affordable drugs to patients worldwide in areas of unmet medical need. Our scientists collaborate across technology and therapeutic platforms to identify and validate novel small molecules and platforms that will enable the rst or best-in-class healthcare solutions of our collaborators. The ISO 27001-certi ed facility is designed to rewall collaborations for scienti c, operational and data exclusivity. We continually add new technologies to our operations, with notable additions over the last two years, including liquid handling systems, such as the Mosquito tal3, mass spectrometers and the IVIS Spectrum in vivo imaging system. IVIS Spectrum combines 2D and 3D optical tomography on a single platform, enabling non-invasive monitoring of disease progression. This, in essence, helps minimise the use of experimental animals. The system is currently being utilised to conduct advanced imaging-based animal studies, including the examination of cell traf cking and gene expression patterns in living animals. The mosquito? tal3 combines speed, accuracy and performance in the crystallisation drop set-up and is currently being used by our structural biology group. The onboarding of Mosquito? tal3 has greatly enhanced our success rate in obtaining protein crystals and co-crystals, helping to accelerate the gene-to-structure determination of our customer programs. We have made signi cant progress in our AI/ML-enabled drug design and validation.
Digital initiatives were rolled out to improve day-to-day operations, lab notebook keeping and customer engagement. We have launched a customer satisfaction survey and 90% of our customers are promoters of our services with peers and colleagues in the industry. In parallel, numerous investments were made to enhance Environment, Health & Safety (EHS) standards in the laboratories. Together, these strategic actions and investments will pave the way for business growth in the years to come. We have onboarded new customer programs in the disease areas of oncology and immuno-inflammation. Targeted therapeutics is a growing area and with our specialisation in disease biology, we are currently supporting several drug discovery programs in this eld. We have also successfully nominated developmental candidates in several of our research programs, in the areas of liver diseases and inflammation. Our scientists have published the research being conducted by the business in reputable scienti c journals. We continue to maintain a healthy pipeline of client programs that can help offset attrition and we continue our efforts towards expanding our business base.
Jubilant Therapeutics operates a highly cost-ef cient and cutting-edge R&D model with a small in-house team that discovers novel drugs from scratch to address unmet medical needs and takes them all the way through advanced human trials. Stalwarts in the eld of oncology from institutions such as Memorial Sloan Kettering, Dana-Farber Cancer Institute etc guide the group as part of the Scienti c Advisory Board.
Jubilant Therapeutics has a robust Intellectual property protection and management process that involves ling and maintaining global rights for our discovery and development programs in all key major global markets. The patents of all our pipeline programs have a long runway ahead of them. As part of the drug development and clinical trials process, the business continues to collaborate with several renowned hospitals and institutions for cancer research and patient treatment. The business has implemented SAP for better process management and control.
Manufacturing
Manufacturing operations continue to be streamlined, with a strong focus on key enablers.
Compliance: Compliance with diverse international regulations to maintain high-quality standards and a global customer base.
Customer service: Heightened awareness of our customer needs and striving towards delivering a quality product on time.
Capacity and Capabilities Enhancement: Suf cient capacity to meet demand as well as respond to market opportunities while implementing technology advancements.
Cost Leadership and Continuous Improvement: Continuously improve our conversion costs to remain competitive and establish a long-term presence in the market. Review and revise our processes using business excellence models and lean strategies.
Continuity: Business continuity through risk mitigation and sustainability measures.
Compliance
As a pharmaceutical manufacturer, our manufacturing facilities are required to comply with all applicable quality and regulatory requirements of the country of origin and the country of export, including ensuring that our quality and manufacturing processes conform to current Good Manufacturing Practices (cGMP).
We are committed to continuous business process improvements using automation and providing timely training to our workers, establishing clear Standard Operating Procedures (SOPs) and process guidelines, which will lead to a reduction in cycle time and improvement in productivity.
We continue to deliver safe and effective products to our clients on time. In the true spirit of continuous improvement, aligned with the latest industry standards and trends, we will continue to make signi cant investments in our people and facilities, strengthen our processes, introduce state-of-the-art technologies and further develop our in-house expertise.
In our Radiopharma business, we operate 45 compounding nuclear pharmacies (Radiopharmacies), including three Positron Emission Tomography (PET) drug manufacturing facilities across twenty-two states in the US. Our products are recognised as reliable and trusted in the industry, as we procure, prepare and deliver high-quality products while fully supporting and complying with the State Boards of Pharmacy (BOP) and USP compounding standards. Our pharmacies are open formulary, providing customers with a full array of options that allow clinicians to achieve the most signi cant bene ts for their patients. In March 2024, the US Food and Drug Administration (FDA) inspected the Orlando Radiopharmacy. The inspection resulted in six observations. Responses to the US FDA inspection observations were provided, along with detailed corrective action plans to improve our processes and systems further. The US FDA has since classi ed the inspection as Voluntary
Action Indicated (VAI). USFDA also inspected our Radiopharmaceutical manufacturing facility at Montreal in
April 2024 and classi ed it as VAI in July
2024. Based on these inspections and the US FDA VAI classi cations, both facilities comply with regard to current good manufacturing practices (cGMP).
The regulatory landscape for compounding radiopharmacy facilities has undergone signi cant enhancements, with the US FDA enforcing the Insanitary Conditions at Compounding Facilities - Guidance for Industry to ensure the highest standards of cleanliness and safety across the industry. State Boards of Pharmacy continue to evolve their regulatory frameworks by embracing and enforcing the USP<825> guidance standards, which provide detailed procedures for handling radiopharmaceuticals in healthcare settings. Our facilities have been proactive in adapting to these changes, ensuring compliance with both new and existing regulations. This ongoing commitment to regulatory adherence not only supports our operational integrity but also reinforces our standing as a trusted and compliant leader in the Radiopharmacy sector.
In anticipation of the US FDAs revision of 21 CFR 212, we are pre-emptively planning a comprehensive gap assessment across our PET sites. This will ensure our practices align with the updated regulations upon their nalisation. Our commitment to regulatory excellence will guide modi cations to our standards, ensuring we not only meet but exceed the revised compliance requirements. This anticipatory approach demonstrates our commitment to quality and safety in PET radiopharmaceutical manufacturing, reinforcing our position as a leader in the industry.
The CMO and Allergy Immunotherapy Business Units, based in the Spokane facility, were inspected by the US FDAs Centre for Biologics Evaluation and Research (CBER) and the Centre for Drug Evaluation and Research (CDER).
The CBER inspection concluded with no observations and the classi cation of the inspection is No Action Indicated (NAI). The CDER inspection concluded with just a few observations for which a corrective action plan was provided to the US FDA.
The CDER inspection has been closed with a classi cation of Voluntary Action
Indicated (VAI). Based on these two inspections and the US FDA NAI and VAI classi cations, the facility is in compliance with regard to current good manufacturing practices (cGMP).
The CMO Montreal facility was inspected by Health Canada in January 2024, resulting in a Compliant GMP rating with no critical observations. The CMO Montreal facility was also inspected by the US Food and Drug Administration (FDA) in June 2024. This resulted in fteen observations and the classi cation of the site remains as Of cial Action Indicated (OAI). To date, over 98% of the Corrective and
Preventive Actions have been completed since the close of the FDA inspection and nearly 95% of the Corrective Actions have been incorporated into a comprehensive Quality Enhancement Plan.
Our Solid Dosage Formulation facility at Roorkee, India, which manufactures and distributes nished solid dosage pharmaceutical products, was inspected by the
US FDA in January 2024. The inspection resulted in four observations in which the Company took prompt and comprehensive corrective action. In April 2024, the FDA categorised the inspection as Voluntary Action Indicated (VAI). Based on this inspection and the US FDA VAI classi cation, this facility is in compliance with regard to current good manufacturing practices (cGMP). In addition, the site was inspected by both the EU and TGA agencies during the scal year. These inspections resulted in no critical observations. The site has already received an
EU-compliant certi cate.
Additionally, the Solid Dosage facility in Salisbury, Maryland, was inspected by the U.S. Food and Drug Administration (FDA) in January 2025. This inspection has since been closed with a classi cation of Voluntary Action Indicated. Based on these inspections and the US FDA VAI classi cations, both facilities are in compliance with regard to current good manufacturing practices (cGMP).
In the CRDMO business, we comply with various international regulations to maintain high-quality standards and serve a global customer base. The US FDA performed an audit at the Nanjangud plant in December 2022, wherein the regulatory agency assigned the inspection classi cation of the API facility as Voluntary Action Indicated (VAI). Based on this inspection and the
US FDA VAI classi cation, this facility is in compliance with regard to current good manufacturing practices (cGMP). Further, TGA Australia inspected our Nanjangud facility in October 2023 and the inspection yielded no critical observations. In 2024, the site was inspected by the Brazilian Health Regulatory Agency (ANVISA), resulting in a GMP-compliant classi cation.
Environment, Health, Safety & Sustainability
For Jubilant Pharmova Limited, Environment, Health & Safety (EHS) compliance is a key decision enabler for any process implementation. Our vision is to achieve and maintain the highest standards of EHS performance, ensuring compliance with regulatory requirements and strengthening our commitment to our stakeholders. Leaving a minimal environmental footprint is integral to our Environmental, Health and Safety (EHS) philosophy.
Over the years, EHS excellence has been extensively promoted as a part of our culture. It is also clearly reflected in our policies on sustainability, EHS, climate change mitigation, energy conservation and biodiversity. Performance reviews across the business regularly examine EHS key performance indicators (both lagging and leading) to reinforce leadership commitment to employee safety, well-being and environmental sustainability. Inputs are also integral to our major business decisions, such as new product development, facility enhancements and contractor vendor relations.
Caring for the environment is a core corporate promise. As part of this commitment, requisite capital expenditure is being incurred on process improvements, as well as the upgradation of environmental management facilities using the latest technologies. While end-of-pipe solutions are implemented, we are also making progress on initiatives aimed at reducing waste at its source. Efforts to process more by-products and waste to make them reusable are paying off in terms of ecological and economic impact.
We are aware of the rapid changes in the business environment, including increased global competition, more stringent customer and societal demands and extensive investor expectations. To tackle these challenges and ensure sustainability, we prioritise excellence in cost, quality and services, treating the Environment, Occupational Health and Safety as a topic of utmost importance.
The Company takes appropriate steps to ensure that our employees, the community at large and the environment, including natural resources, are protected. On the road to achieving excellence, we have adopted a top-down approach and have been enhancing the impact of initiatives by making them a line function responsibility through active employee consultation and participation. Efforts have been regularly implemented to drive a common governance approach for EHS across the board and to adopt management programs and systems that follow a standard framework for deployment while also allowing for tailoring to local regulatory and other location-speci c requirements.
The Companys operations span multiple geographical regions and are subject to a diverse range of Environmental, Health and Safety (EHS) laws and regulations. In North America, we are regulated by various safety, health and environmental agencies and authorities, including the United States Environmental Protection Agency (US EPA), Occupational Safety and Health Administration (OSHA), United States Nuclear Regulatory Safety Commission, Committee on Standards, Equity, Health and Safety at Work
(CNESST, Quebec), Canadian Nuclear Safety Commission (CNSC), United States Boards of Pharmacy and Environment and Climate Change Canada. In India, we are regulated by various environmental agencies and authorities, including the Central Pollution Control Board (CPCB) and State Pollution Control Boards (SPCBs).
During FY25, we have set new sustainability goals for FY29, covering key EHS indicators. The Company has also revised its supplier sustainability policy this year and has already rolled out across Indian operations. This addresses our suppliers EHS performance, as well as their social and climate change performance. In FY23, we deployed the Conformity tool for compliance management across our facilities in North America. The tool helps link compliance to our processes and, where necessary, modify business processespolicies. The tool provides real-time MIS capability for the reviewerapprover and management. The Board reviews the compliance reports periodically. We developed and deployed an EHS management system, which provides the structure for implementing proactive risk management solutions to ensure the safety of our people, ensure compliance with internal and external requirements, drive continuous improvement and support the overall strategy to operate in a safe and sustainable environment.
All our facilities have a process for employees to report workplace EHS issues and concerns. We also encourage dialogue with employees through educational initiatives and functional and cross-functional committees. Our leadership team members are required to conduct regular GEMBA walks, not only to identify and address improvement opportunities but also to engage in EHS-focused conversations as part of building a culture of safety and care. At our manufacturing facility and Radiopharmacies, EHS programs are implemented, including training and awareness initiatives to keep our employees, community and other stakeholders informed about key EHS aspects relevant to their operations. Contractors working at our facilities are educated and trained to conduct their activities safely and in an environmentally responsible manner. The operations leadership team reviews the progress made by the facilities on their EHS management system implementation during the periodic EHS call.
Our manufacturing facilities in India are well-equipped with Occupational Health Centres (OHCs) run by experienced professionals. A comprehensive health assessment program is in place for all individuals working in our various facilities. The OHCs, equipped with the latest euipment, provide curative, advisory and health promotion services to employees. In North America, we work closely with local healthcare providers to ensure timely medical support for our employees.
During FY25, we upgraded our re protection system by installing it at our Nanjangud facility in India. We have also implemented an EHS Transformation scorecard system at our Nanjangud and Jubilant Biosys Limiteds Facilities in India for FY25. We achieved zero LTIFR (Loss time injury frequency rate) from FY23 onwards in our Indian facilities.
We have regularly made investments in upgrading process safety and enhancing process controls at our facilities. We employ EHS web-based solutions (Gensuite andor EHS Insight), which are cloud-based management systems that provide integrated EHS applications within a suite of tools speci c to each business. The applications are related to the management of corrective actions, incident recording, incident investigation, data mining, auto noti cations and compliance calendars, among others. These systems enable greater flexibility in data collection, aligning with our business needs and driving consistency in tracking EHS challenges, ultimately improving our overall performance.
We worked on enhancing the capabilities of these websites as part of our ongoing improvement strategy to provide a better user experience and facilitate more accurate data reporting. One such enhancement is the development of safety observations reporting in Jubilant Pharma Limited, covering all of our North American facilities. Safety observation tools use computer and mobile technology to capture safe and unsafe behaviours and conditions, which are tracked in the system until closure. Another enhancement includes the ability to unify all incident and accident reporting under one standard reporting system, providing a better user experience and enhanced tracking and reporting of data.
Our Radiopharmacies business in the US has introduced a driver safety training program called Driver Insights, offered in collaboration with our fleet management vendor, ARI. This program includes an electronically delivered Driver Skill Assessment and training to address speci c skill gaps. Our fleet in the US also utilises GeoTab, a
GPS-based telematics solution that provides crucial driver behaviour information and helps ensure the overall ef cient operation of our vehicles.
The Jubilant Radiopharmacies network across the US completed 68 inspections by environmental agencies, health agencies, radiation agencies and re departments that did not result in Notices of Noncompliance (NONs). Canadian Nuclear Safety Commission (CNSC) performed a compliance inspection of the Radiopharmaceuticals business activities under the Nuclear Substance and Radiation Device License. No notices of non-compliance were issued as part of this inspection. There were 12 recommendations focused on improving the training program, which we responded to and followed up on within the allotted time. Our Montreal facilitys CNSC license was renewed until 2029 without any additional conditions and the facility also implemented high-risk targeted radiation audits in 2023. CNESST certi cation was also implemented in 2023, showcasing our unwavering dedication to health and safety.
JHS Montreal (JHSM) has joined a prevention mutual, which is a group of employers who choose to engage together in a prevention approach which promotes the prevention of work accidents and occupational diseases, the rehabilitation of workers who suffer a workplace accident or illness, the return to work after a work-related injury or illness. ). By joining a prevention mutual, JHSM bene ts from structured support for managing health and safety in your workplace and a personalised group rate that takes into account the efforts JHSM and all the members of the mutual invest to provide a safer workplace for your workers. For two years in a row, the
City of Spokane Water Reclamation Facility has awarded Jubilant Hollisterstier a
Certi cate of Recognition for 100% compliance.
Our Roorkee, India facility has full-fledged effluent treatment and sewage treatment facilities with capacities of 130,000 litres and 70,000 litres, respectively. It is a Zero Liquid Discharge facility and the treated water is used for irrigation in accordance with the Consolidated Consent and Authorisation (CCA).
Our API facility at Nanjangud, India, operates on a Zero Liquid Discharge (ZLD) basis. Actions towards water conservation measures, improvements in the segregation of effluent streams and the adoption of new technologies, such as the SCALEBAN for cooling towers, have resulted in improved ZLD operations with reduced operational costs. The construction of additional infrastructures has helped achieve improvement in compliance with hazardous waste management rules. An enhanced focus on hazardous waste destruction through co-incineration in cement kilns is progressively reducing the environmental footprint. Also introduced was PNG (piped natural gas) to replace furnace oil in the boiler at the Nanjangud site as a measure to reduce the sites carbon footprint. We constructed rainwater harvesting pits at our Najangud site and utilised approximately 1,500 KL of rainwater from there for gardening purposes.
We continue to engage external subject matter experts to assess our operations and we jointly work with their expertise to enhance our risk reduction efforts. These types of engagements include process safety, machinery safety and lockout tagout, electrical safety, ergonomics, industrial hygiene, investigation and root cause analysis, among others. Training sessions are planned for this scal year as part of our competency-building efforts. We are working to strengthen our safety management system as part of our Occupational Health and Safety strategy, which includes implementing global OH&S Standards, building competencies of our people, developing safety KPIs and driving safety governance across all levels of the organisation up to the top management level.
Comprehensive safety improvement and capacity-building exercises have been undertaken to enhance the knowledge, competency, expertise and commitment level of our people through the services of an external safety consultant.
Customer Service
Our operations are fundamentally focused on Supply Level Adherence (SLA) and Right First Time (RFT) principles. By achieving excellence in these two key metrics, high levels of customer service are automatically achieved. Bringing customer centricity into our operations by leveraging excellent tools and methodologies to unlock Overall Plant Ef ciency (OPE) and On-Time in Full (OTIF) is important to achieve a competitive advantage and support business growth.
Jubilant Radiopharmacies received a 9.4 NPS (Net Promoter Score) in a recent broad customer survey. That underscores and con rms that customers recognise Jubilants commitment to customer service.
In Allergy Immunotherapy business, customer service has been a focal point of the Companys commitment to excellence. Under concerted leadership, a comprehensive overhaul of customer service practices was initiated. Through the implementation of new strategies for collecting qualitative feedback, the Company gains invaluable insights into customer needs and preferences. Identifying and rectifying system inef ciencies was a critical component of the customer service enhancement initiative. By addressing bottlenecks and streamlining processes, the Company improved response times and delivered a more seamless experience for customers. The Companys knowledgeable sales team plays a pivotal role in the customer service ecosystem. With their expertise and dedication, they serve as trusted advisors, providing invaluable support and guidance to customers. Their in-depth understanding of products and services enables them to provide tailored solutions that enhance the overall customer experience. The commitment to customer service extends to the support network, which includes medical science liaisons dedicated to providing healthcare professionals with the latest scienti c information and insights. These professionals serve as a bridge between customers and scienti c expertise, ensuring access to resources for informed decisions and high-quality care delivery.
In our CDMO Sterile Injectables Business, heightened awareness of our customers needs is aligned with our Commercial Excellence enabler, allowing us to deliver high-quality products right the rst time in accordance with the
Customer Service Level Agreement (SLA). One example of this is releasing batches within 45 days of production (last year, the actual release time was over 75 days).
In the Generics Business, we have placed greater emphasis on ensuring product robustness over the last couple of years. This was done for all our key products for the non-US markets. As a result, batch rejections have decreased and there has been a signi cant improvement in OTIF. As a result, we could ful l our commitments to customers on time. For the US business, we maintain continuous engagement with third-party contract manufacturers to ensure uninterrupted supplies.
In CRDMO business, we continue to strive towards delivering a quality product on time. Therefore, we have increased our OTIF (On Time In Full) for the top 5 products.
Capacity and Capabilities Enhancement
In the Radiopharma business, for FY24, with heightened awareness of customer needs, 97% of all products were manufactured on time and 98% of products were delivered on time. A strategic master plan for the manufacturing and quality control facility was completed to maintain the highest quality standards in accordance with diverse international regulations, support the demands of all markets and improve conversion costs. In addition, new processes and equipment were introduced to the sterilisation process to ensure business continuity in sterile product manufacturing.
A capacity increase plan for Ruby-Fill? generators manufacturing was initiated over the last couple of years. The plan started with equipment automation, resulting in a 15% capacity increase and process optimisation in two phases. Phase I was completed with a 50% increase in capacity. The design, feasibility and initial testing studies were completed in FY24. This process will add another 50% capacity increase to the radiopharmaceutical manufacturing installation. In addition, new processes were implemented to support market growth testing requirements.
In the radiopharmacy, capacity and capability enhancements have been substantial in FY24 and FY25, particularly with the state-of-the-art clean room upgrades at all of Jubilants radiopharmacies. New hoods were installed at Oakland and New York sites to manage and dispense MIBG.
This year also marked a signi cant enhancement at our Boston, MA, facility with the integration of a theranostic centre of excellence. This centre enables the site to dispense radiotherapies from a state-of-the-art radiotherapy compounding facility, further expanding our capabilities in providing cutting-edge treatment options. This development not only enhances our service offerings but also positions us at the forefront of theranostic advances, supporting the growing demand for personalised medicine. Our open formulary approach ensures that clinicians have access to a comprehensive range of options, enhancing the therapeutic outcomes for patients while supporting personalised medicine. In FY25 we started a capex project to add 6 new PET radiopharmacies by investing US $50 million.
In our role as a CDMO, weve supported ARTMS in developing their innovative solid target technology, a collaboration that extends to assisting their partners. This work is crucial, as it enables these partners to utilise the technology for labelling their commercial products, thus enhancing the availability of advanced PET diagnostics in the market.
Our strategic developments are advancing our infrastructure to handle and dispense PET radiopharmaceuticals with high energy levels, such as those with 511 keV energy, ensuring clinicians and patients have access to vital, cutting-edge PET diagnostics. This initiative, alongside our commitment to ensuring seamless Patient-Ready Doses, underscores our unwavering committment to operational excellence and staying at the forefront of innovation in nuclear medicine.
In the Allergy Immunotherapy business, to meet market demand, the company has increased its lyophilisation capacity and continues to grow this capability. Ongoing investment in the US-based manufacturing facility will ensure a consistent and reliable supply of key products for distribution in both domestic and international markets. The Company continues to invest in upgrading facilities and equipment to meet growing demands and current compliance standards.
In our CDMO Sterile Injectables Business, Operational Excellence is key for us. In this regard, we continue to balance our liquid and lyophilisation capacity on our existing lines while implementing technological advancements, including our new isolator technology on our expansion lines. At both of our CDMO facilities - Spokane, US and Montreal, Canada - equipment reliability programs have been initiated and several initiatives are in progress to strengthen and improve processes related to equipment reliability, maintenance, engineering capabilities, spare parts management and overall plant capacity.
At our CDMO operations in Montreal, Canada, we upgraded our ophthalmic
lling lines for both ointment and liquid lls while also procuring additional
Customers for both formats. The new ophthalmic line meets the latest cGMP standards and incorporates the latest technology for manufacturing liquid products and is expected to be fully quali ed by the end of FY26.
Our Roorkee, India manufacturing site is equipped with state-of-the-art facilities and machinery having suf cient capacity to cater to the growing demand. Several capacity-debottlenecking projects have been implemented and facilities and processes have been upgraded to enhance Good Manufacturing Practice (GMP) at our formulations facility in Roorkee, India. Our continued engagement and collaboration with CMOs will also ensure our ability to cater to the increased demand for select products.
In CRDMO business, following our continuous pursuit of excellence and innovation, we have established six Centres of Excellence (CoEs) for specialised chemistry. These CoEs are not just facilities - they are the embodiment of our commitment to providing high-quality, specialised chemistry services at an accelerated pace. Each CoE is equipped with a dedicated team of experts and state-of-the-art technology, ensuring that we stay at the forefront of chemical research and development. Our teams work tirelessly to provide solutions that are not only effective but also tailored to meet the unique needs of our clients. We have received excellent feedback with increased FTEs in lipid chemistry, from multiple customers. We have integrated the capabilities of Jubilant Biosys Limited and API, Nanjangud, to deliver a seamless service experience to our customers. Recognising the dynamic nature of customer demands, we have fostered a uni ed team comprising members from PRD (Noida) and Tech Transfer (Nanjangud). Our strategy involves the optimal utilisation of our resources. We are capitalising on the Nanjangud site for CDMO (Low-mid scale GMP) operations and the HiPo Suite at Greater Noida for CDMO (small scale GMP) operations. This strategic allocation allows us to cater to a wide range of customer requirements, thereby enhancing our service delivery. The synergy between various teams and resources will propel us forward in our journey of growth and customer satisfaction. As a result, we have been awarded three NCE (New Chemical Entities) API projects for development and manufacturing in Clinical Phases. We have suf cient capacity to meet demand and respond to market opportunities while implementing technological advancements.
In the CDMO API business, in FY25, we increased our capacity by 104TPA and OPE (Overall Productivity Effectiveness) by 6-15% in the top 5 products. Through the Six Sigma approach and 6S, we have implemented more than 45 improvement projects.
Cost Leadership & Continuous Improvements
Our focus has been on optimising conversion costs without compromising our quality and customer service standards and several initiatives have been undertaken to reduce conversion costs.
In the Radiopharma business, our bottoms-up Business Excellence initiative named FOKUS has allowed employees to come up with novel ideas and suggestions to bring ef ciencies and reduce or eliminate cost or waste in our processes. Our focus on training and process improvements led to a reduction in discards, waste and costs, as well as continuous improvement.
Radiopharmacies have developed next-generation predictive modelling for Mo-99 Tc-99m demand across our Radiopharmacy network, resulting in approximately US $3.5 million in annual cost savings since FY23. Radiopharmacy operations Mo-99 generator ef ciency reached an all-time high in FY25 and is best in class within the nuclear medicine industry. Predictive planning allows optimisation during holiday seasons as well as seasonal highs and lows in dose volume. Arti cial Intelligence
Modelling was introduced in FY25 to further enhance our predictive modelling tool.
Additionally, we reduced third-party courier expenses by approximately US $2.8 million since FY23 by implementing a route optimiser and strategic hiring events for new in-house medical couriers. Further implementation of the Route Planner tool allowed the optimisation of complex routes, providing labor-effective solutions. With the use of advanced analytics, we identi ed opportunities for signi cant product cost reduction across several product lines by implementing and rolling out a newly developed production optimiser tool to reduce radiopharmaceutical kit consumption.
In the Allergy Immunotherapy Business, the Company has initiated several strategic improvements across processes, quality and management systems to align with industry best practices and enhance operational ef ciency. These improvements are part of an ongoing effort to meet growing demands, enhance ef ciency and comply with current and future regulatory standards.
Our manufacturing facilities in Spokane, US, have led structured improvement projects designed to deliver signi cant conversion cost savings while also improving safety, deviation rate, productivity, batch rejections and service levels. We have undertaken numerous energy-saving projects to reduce our utility costs. Several automation projects and increased batch sizes in our operations are leading to ef cient headcount utilisation. The most signi cant changes recently are the signi cant improvement in batch release time and RFT for new product introductions. Speci cally, batch release time has improved over the last year, FY24 from 75+ days to <45 days and the target for FY26 is <40 days.
In the Generics Business, our employees have come up with novel ideas and suggestions to bring ef ciencies and reduce or eliminate costs and waste in our processes. Our focus on training and process improvements resulted in a reduction in discards and an improvement in Right First Time (RFT) rates. As part of its continuous effort to achieve cost ef ciencies and process improvements, the Company has decided to close the manufacturing operations of its solid dosage formulation facility in Salisbury, Maryland, USA and transition from in-house manufacturing to outsourced manufacturing by selected US FDA-approved Contract Manufacturing Organisations (CMOs) for the US market.
At the API facility in Nanjangud, in FY25, we realised cost savings of more than
19 crores through continuous improvement projects by creating a Task Force team that follows the lean approach. At the API facility in Nanjangud, we continue to identify waste across the value chain and eliminate it using a structured approach. In FY25, we have improved the yield in key products by 2% to 10%.
Continuity
Business continuity is essential for sustenance and the Company has already established a sound strategy. We also executed several risk mitigation projects to qualify alternative sites for key products and to qualify alternative sources for key active ingredients, excipients and components. This provides greater con dence in our overall supply chain with our customers. We see our sustainability programs as key enablers for ensuring business continuity. To bring about a cultural transformation across the organisation with a safety and quality mindset, programs on the Companys Values, safety management system and quality culture transformation continue to be carried out.
In the Allergy immunotherapy business, ensuring uninterrupted business operations is paramount for the Company, which has proactively devised a robust strategy to address this need. Through diligent efforts, numerous risk mitigation initiatives have been implemented to identify and secure alternative sites for critical products and diversify sources for key active ingredients, excipients and components. These endeavours bolster supply chain resilience and instil greater con dence among customers. Fostering a culture that prioritises safety and quality remains a top priority. The Company is committed to fostering a cultural shift across the organisation, emphasising the importance of safety and quality in every aspect of work. To achieve this, ongoing programs centred on the Companys core values, safety management systems and quality culture transformation are being diligently executed. These initiatives serve as catalysts for instilling a collective mindset that prioritises safety and quality excellence throughout the entire workforce.
At Nanjangud, India, a comprehensive asset health assessment exercise is conducted to replace ageing assets in a phased manner, thereby avoiding business interruptions and enhancing compliance levels.
Supply Chain
Globally, supply chains have remained a bottleneck in the last 1-2 years. However, the Supply Chain at Jubilant Pharmova Limited continued to focus on ensuring the availability of all inputs in a timely manner to maintain manufacturing operations and deliver our products to customers worldwide. This was achieved despite global supply constraints and increased volatility in the prices of most of the inputs. The Russia?
Ukraine conflict and the Red Sea crisis have signi cantly impacted metal prices and logistics costs across the globe. Global logistics continued to remain a challenge over the last couple of years.
In Radiopharmacies for FY25, the Supply Chain was able to steer clear of all supply chain disruptions related to critical operating materials and components due to the implementation of a multiple sourcing plan, as well as a proactive approach to nding alternate providers of key consumable components. We diversi ed key elements of our supply chain and successfully navigated a global shortage of Tc-99, with 0% of doses dispensed. Delivery vehicle procurement, following the COVID-19 pandemic, saw availability decline to critical levels, driving up maintenance and repair costs for ageing vehicles. This issue has been resolved with the implementation of Hyundai fleet services, which was able to deliver in FY24. It is expected that moving to to smaller, more fuel-ef cient vehicles and replacing older ones will result in considerable savings in FY25 and beyond. A multi-year contract with Eckert & Ziegler has secured Jubilants critical Gallium-68 supply. Contract negotiations for key Mo-99 generator procurement are ongoing, with the existing contract expiring in late 2024. Different manufacturers are currently being considered to reduce supply chain risk. The establishment of a central warehouse in Memphis, TN, helped improve inventory management, reducing the inventory cycle to 30 days or less and lowering costs due to expiration.
At CDMO Sterile Injectable, despite numerous supply chain challenges with components and parts, we have been able to meet aggressive timeframes and leverage our parent company to address broader supply challenges. In addition, as part of the USG IB consortium (discussed earlier), JHS holds a DPAS certi cation rating, enabling JHS to expedite long-lead time challenges, particularly those related to the pandemic or other USG-required projects. This has been bene cial for our expansion project, particularly in procuring long-lead time supplies and equipment. Lastly, this is a key differentiator for JHS and a customer need focused on procuring the entire supply chain on-shore.
In the CRDMO Business, with successful registration under the Pharmaceutical Supply Chain Initiative (PSCI), Jubilant Biosys Limited will create a path for Responsible Supply Chain Management. Many initial hiccups and challenges in ERP have been overcome with good process standardisation. More ERP automation for sourcing capabilities is being considered and is underway on the design front. CDMO dynamic supplier blend between Nanjangud and Biosys units is becoming critical for key raw material sourcing. We intend to build a customised supplier base that is currently fragmented with various capabilities and limitations. Dependency on Indian sources has drastically increased the de-risking of operations and this approach has been successful with no major failures or ndings. The
65% reduction in the discovery phase supply timeline has effectively supported our dependency on indigenous procurement, as opposed to previous imports from China. The Supply Chain continues to support projects with agility, integrity and ef ciency, which is crucial in the current market for service-based collaborations. While we do so, we will continue to uphold compliance as an integral part of our business.
Business Excellence
We are striving towards customer-centricity in our processes by leveraging excellence in our methodologies. Our goal is to achieve ef ciencies and make our businesses more sustainable. Identi cation of waste across the value chain and its elimination by improving product quality, service levels, productivity, planning and yields are integral to our approach.
To bring about a cultural change across the organisation with a safety and quality rst mindset, programs such as
Values work-shop, Integrated Process Teams and Lean Workflow Management are undertaken consistently. Further, cross-functional team collaboration has been actively encouraged for solving business problems using the Lean Six Sigma approach.
There is a high level of commitment towards leveraging new technologies and automation to deliver breakthrough results and achieve competitive advantage. Dynamic project management utilising Smartsheet, the use of Power BI dashboards and the initiation of MES deployment are setting the path for ef cient and agile operations.
In continuation of our digitalisation journey, the use of Arti cial Intelligence and Machine Learning-backed logistics planning and schedule optimiser tools has helped us leverage faster, more ef cient and reliable deliveries to our customers. Design space of key products optimised using Python-based advanced modelling techniques and improved product robustness.
Digital & IT Transformation
The rapid pace of digital transformation is reshaping industries worldwide and in the Pharmaceuticals and Healthcare sector, this evolution is more than a technological upgrade?its a necessity. As global challenges demand faster innovation, greater ef ciency and enhanced patient outcomes, embracing cutting-edge technologies is no longer optional but fundamental to staying ahead.
At Jubilant Pharmova Limited, we recognise that digital transformation is not just about adopting new tools?its about rede ning the way we operate, optimise and innovate. By harnessing Arti cial
Intelligence and Machine Learning, the Internet of Things (IoT), Robotics and Mixed Reality, we are revolutionising our processes, improving agility, minimising errors and enhancing compliance. Most importantly, we are equipping ourselves to navigate future disruptions with con dence and precision.
In FY25, Jubilant Pharmova Limited launched several initiatives, including enhancing API molecule yields using advanced AIML tools, developing analytics-based forecasting models to predict pharmacy demand for doses and utilising AI for automatic RFP responses to improve quality and win rates. Additionally, we integrated AI adoption with Copilot to streamline processes and boost productivity across various functions. Through discovery phases and agile delivery methods, we are delivering results in sprints, aiming to realise these bene ts by year-end fully.
To support these initiatives and ensure effective monitoring and management, we developed a central Data Lake and Insights platform with over 30 dashboards. This platform powers various visualisations and dashboards designed to track digital business KPIs across Jubilant Pharmova Limiteds businesses and functions. It provides actionable insights, visualisation and reporting, serving as a single source of truth and enables data-driven decision-making at all organisational levels.
This year, we further strengthened our cybersecurity framework, building upon last years foundational progress. Our focus remained on operational excellence, proactive threat management and compliance readiness. We continued to mature our Managed Security Services model, expanding the capabilities of our 247 Security Operations Centre (SOC) and deepening collaboration with our independent security services partner to drive real-time threat detection and response.
Signi cant advancements were made across key domains, including Privilege Access Management, GRC Automation, Web Security, People Security Management and Identity Threat Detection and Response. These efforts enhanced visibility and control across hybrid and multi-cloud environments, reducing our exposure to emerging threats.
Our team successfully navigated and closed multiple third-party cyber assessments and customer-led audits, reinforcing trust and assurance in our cybersecurity governance practices. These initiatives underscore our unwavering commitment to protecting digital assets, supporting business continuity and aligning with evolving regulatory expectations.
In FY25, several key initiatives were undertaken to enhance processes and systems, resulting in signi cant productivity gains and technological upgrades. Under the HRIS portal, the Full & Final statement was redesigned for more ef cient nancial processing.
New hire forms for IT and the FTE allocation upload process for North America streamlined onboarding and resource allocation. The integration of the BillableNon-Billable Module with the PPM Tool (Sciforma) and the launch of the New Hire Experience dashboard enhanced project management and employee engagement. Additionally, a BI dashboard for HR was developed to monitor iteration rates, providing valuable insights into employee turnover.
The eAnalytics application was upgraded to the latest technologies, enhancing data processing and analysis. The IMS - Vendor Catalogue module improved supply chain ef ciency by integrating with over
10 vendors. A vendor management portal for Jubilant Pharma streamlined procurement by integrating RFQ creation, proposal submission and SAP approval processes. The career portal was transformed to simplify job applications, improve user experience design and integrate with Indeed. Additionally, an initiative was taken to replace the Gensuit portal with the in-house Sanchetna application to automate safety workflows. These efforts contributed to a 30% reduction in support tickets and improved the SLA from 93% to 96%.
We ensured 99.99% availability of IT infrastructure for applications and end users, maintaining high reliability. Multiple initiatives were undertaken last
scal year, including the transformation of the Wide Area Network across the North American region, which enhanced availability through a new SLA-based contract that guarantees uptime. This year, we plan to migrate VOIP services for Radio Pharmacies, further improving communication capabilities. Additionally, for India connectivity, we initiated bandwidth upgrades at key locations. We transitioned from RF
(radio waves) to Fiber Optics, ensuring faster, more reliable and interference-free connectivity for greater reliability and sustainability, alongside a hardware upgrade.
The team focused on ensuring that all devices were remotely managed. To achieve this, we rolled out Intune for end users and rebuilt System Centre Con guration
Manager (SCCM), increasing compliance levels from 60% to over 85% year-over-year. A new cloud-based ticketing tool is currently being deployed, designed to improve ticket management for end users, admins and HRIS. With features such as ticket tracking, expedited resolution and self-healing functionalities for password resets, we anticipate further ef ciency improvements. Additionally, we continue our efforts to organise service camps for user laptops and desktops and implement automation in our backend infrastructure to streamline IT operations further.
Last scal year, we maintained high uptime while optimising cloud resources by identifying and recon guring inef ciencies, ensuring streamlined infrastructure management. This year, we are collaborating with application owners to further optimise resources, with plans to implement FinOps tools to explore new opportunities for increased ef ciency. Additionally, we are evaluating advanced security measures, including transitioning from traditional snapshot backups to air-gapped solutions for enhanced protection.
As we stand on the brink of a new era in digital transformation, Jubilant Pharmova Limited is poised to accelerate its evolution, leveraging emerging technologies and strategic investments. The convergence of AI, automation and advanced analytics is not just reshaping the way we operate?it is enabling us to reimagine possibilities, drive innovation and elevate industry standards.
In the coming year, our focus will shift from foundational digital initiatives to unlocking new frontiers in intelligent automation, hyper-personalisation and predictive analytics. By embedding AI deeper into our operations?from drug discovery to supply chain optimisation we aim to enhance ef ciency while pioneering solutions that anticipate future healthcare challenges.
Our commitment to cybersecurity will also deepen, ensuring that as we scale digital innovations, we do so with a forti ed security posture that safeguards critical assets and maintains trust with our stakeholders. Additionally, investments in digital talent and collaborative ecosystems will further amplify our ability to transform ideas into impactful, future-ready solutions.
Jubilant Pharmova Limited is not just adapting to digital transformation?it is driving it. As we harness technology to rede ne our industry and unlock new possibilities, we are committed to building a future where agility, intelligence and innovation converge to create lasting value for our customers, partners and society at large.
Human Resources
We believe in the Employee First culture, driven by our Promise of Caring, Sharing, Growing.
We are constantly listening to our employees and remain agile and responsive to their evolving needs. We partnered with the prestigious global organisation Great Place to Work (GPTW)? to undertake an employees survey that helped highlight our strengths and provide insights into areas for improvement, turning them into actionable goals. The survey garnered an engagement score of over 80%?a testament to our peoples faith in Jubilant Pharmova Limited. The Jubilant Pharmova (India) is now certi ed as a
Great Place to Work.
In our quest to excel, we are continuously focused on delivering a superior and consistent employee experience, prioritising the holistic well-being of our people. To enable a consistent experience, we are committed to working towards capability and culture building, Agility, Total Rewards and Digital Transformation, all the while upholding a culture of safety and high quality.
Talent pipeline and an Inclusive culture
We revamped and relaunched our Talent and Succession Planning 2.0 program to create a robust succession pipeline within the organisation. Our multiple initiatives enhance sensitisation and provide inclusive growth to foster diversity and inclusion within the organisation. We initiated the hiring of all-women batches at Jubilant Biosys Limited to promote gender equality both within the organisation and beyond. We actively support these young women at every step to ensure a smooth transition and long-term success. This includes structured mentorship from experienced women leaders, providing them with the guidance, con dence and industry exposure needed to thrive. Another unique initiative includes CEO councils that have a majority of representation from young women. These councils have direct access to the CEO and guide with suggestions to improve workplace practices, making us the employer of choice. We launched the Jubilant Women in Leadership program at Jubilant Radiopharma to provide exposure, training and support for women.
Developing Leaders
Our talented workforce is our greatest asset in achieving continued business success. To ensure they are future-ready, we are committed to fostering a culture of continuous learning and leadership development. We are cultivating sustainable leadership?leaders who will guide our company now and chart the course for a prosperous future.
Aligned with this philosophy, we launched the Jubilant Centre for Learning, which hosts multiple academies, including the Leadership Academy, Sales Academy, Manufacturing Excellence Academy and Supply Chain Academy. Through structured classroom training and a cutting-edge digital learning platform, these academies equip our employees with the skills, mindset and competencies they need to thrive.
Building a high-performance and rewarding culture
In our pursuit of excellence, we meticulously craft a high-performance culture within our organisation, starting with our robust performance management process. Through initiatives such as the Applause program and the prestigious Chairmens Annual Awards, we not only celebrate exceptional accomplishments but also ingrain a culture of appreciation and recognition. Our culture of high performance is further strengthened by providing continuous feedback, pay for performance and offering role-based promotions. This unleashes the full potential of our people and drives us towards collective success.
Corporate Social Responsibility (CSR)
CSR constitutes a fundamental pillar of Jubilants corporate philosophy and is implemented in strict adherence to Section 135, read with Schedule VII of the Companies Act, 2013. The initiatives are strategically aligned with the United Nations Sustainable Development Goals (SDGs).
The Jubilant Bhatia Foundation (JBF), founded in 2007, serves as the not-for-pro t arm of the Jubilant Bhartia Group. It concentrates on CSR initiatives in Healthcare, Education and Livelihood through a 4P (Public-Private-People-Partnership) model, aiming to uplift and add value to the communities surrounding the companys operational areas.
In FY25, JBF followed its vision of promoting progressive social change by forming strategic multi-stakeholder partnerships. These collaborations focus on generating and sharing knowledge, experiential learning and cultivating an entrepreneurial ecosystem. The Foundations efforts are dedicated to improving the quality of life for communities near their manufacturing facilities. For detailed information, you can visit www.jubilantbhartiafoundation.com
The brief information on CSR activities carried out by the Company is stated below:
Healthcare: Providing affordable, basic and preventive healthcare
Arogya- Providing affordable basic & preventive health care: The Foundation caters to around two lakhs of population in the villages near manufacturing units of Jubilant Pharmova Limited in Nanjangud and Roorkee in India, through its initiative Jubicare to achieve good health and well-being, promote health-seeking behaviour and provide effective basic healthcare to the community through basic healthcare services through Mobile Dispensary for patients in the community.
Education: Strengthening the Rural Education system through various education-centric programs in government schools
Muskaan - Supporting Rural Government Primary Education: The Foundation aims at strengthening education and learning environment in rural areas in over 100 schools and more than 33,000 bene ciaries
(students & teachers) through various initiatives as below: a) Khushiyon Ki Pathshala: To Create a more inclusive and child-friendly society by training teachers and the youths to act as facilitators to transform the educational environment, ensuring that students thrive and imbibe values along with 21st-century skills. The program has a key component of training youths and teachers with the skills to make schools more inclusive, fostering an environment where every child feels welcome and supported. The program helps youths and teachers develop their personalities, enhancing their ability to connect with and support their students effectively. b) Mobile Science Lab: The initiative provides hands-on science education to students from rural backgrounds. The establishment of science labs in schools intends to enhance the scienti c understanding and curiosity of students in rural areas, making science education accessible and interactive. c) School Digitisation: To bridge the urban-rural divide and enhance the learning mode in government schools, the Foundation is implementing a school digitisation program. The Foundation aims to strengthen the education and learning environment in rural areas, bene ting seven schools and over 5,000 bene ciaries
(students and teachers) through school digitisation and school strengthening programs. To bridge the urban and rural divide and to enhance the mode of learning in government schools, the foundation is implementing a school digitisation program through:
Edulab Programme: Focuses on improving the learning needs of students by integrating advanced educational tools and methodologies.
HP Digital Programme: Provides students with access to digital education, ensuring they have the tools and resources needed for modern learning. d) Muskaan Kitaab Ghar: The Foundation established a library in rural schools to increase the accessibility of books to every child, thereby improving reading and learning parameters and reducing absenteeism from schools.
Livelihood: Working towards providing sustainable livelihood
Nayee Disha - Creating Sustainable livelihood opportunities for all. Reaching out to community members: To empower rural youth and women around plant locations by promoting self-employment through skill development and enterprise development.
Skill Development - located at four sites, these centres offer training in various trades.
Samriddhi - to empower women by promoting entrepreneurial ventures and creating sustainable income sources through locally nurtured businesses like Uniform Stitching Centre. This project, operational in Nanjangud, focuses on empowering women by involving them in stitching uniforms for companies around its premises. It aims to provide a sustainable income source and promote local entrepreneurship.
BHARAT IMPACT Jubilant Bhartia Centre for Social Entrepreneurship:
The centre focuses on incubation, education and research to support social entrepreneurs.
Knowledge Partner: Indian Institute of Management Ahmedabad (IIM A) serves as the knowledge partner, providing expertise and guidance. Infrastructure Development: Ongoing work to establish the necessary infrastructure for the centre.
Cohort Formation - Impact Quest launched the rst 15 members cohort across the nation.
At Jubilant Pharmova Limited, an Internal Financial Controls (IFC) system has been established, incorporating all the above elements. In addition, our Company has a transparent framework for periodic evaluation of Internal Financial Controls, which includes annual testing of the operational effectiveness of internal controls, perpetual internal audit exercises and quarterly online controls self-assessments through the Controls Manager software thereby reinforcing our commitment to adopting the best corporate governance practices.
The policy and procedure adopted by the Company to adhere to IFC elements are given below:
Orderly and Ef cient Conduct of Business
The Company has an established organisational structure, which de nes the roles and responsibility relationship.
The Company has a formal nancial planning and budgeting system that encompasses both short-term and long-term planning. To ensure that decisions are made and actions taken at an appropriate level, the Board of Directors of the Company have formulated the Delegation of Authority, which has been designed to ensure that there is a judicious balance of authority and responsibility. Adherence to the Delegation of Authority is a part of the internal audit plan. The Company also has a risk management framework, which has been discussed under the heading Our Vision on Risk Management.
We have implemented a web-based automated compliance management and reporting system. The objective of the system is to ensure that compliance is regularly monitored and controlled, with a view to supporting the Companys business objectives and corporate policy requirements. The system includes a comprehensive checklist to ensure compliance with the laws and regulations applicable to all Company plants and of ces. To ensure timely and effective compliance, the compliance status is monitored in real time by the respective functions. Pursuant to the Listing Regulations, the Company Secretary and Compliance Of cer present a compliance certi cate to the Board of Directors every quarter.
Safeguarding Assets, Adherence to the Companys Policies
The Company has taken an Industrial All Risk (IAR) policy for its plants as well as a
re policy for the Corporate Of ce to safeguard its assets. It also carries out physical veri cation of its assets.
The Company has two-tier policies and procedures: Entity-Level Controls and Process-Level Controls. The entity-level controls include a comprehensive Code of Conduct. The Company also has a Whistle Blower policy and any employee of the Company can directly write to the Ombudsperson. We also have process-level controls, which cover a wide range of key operating, nancial and compliance-related areas, including Accounting, Order to Cash, Procurement to Payment, Inventory and Production, Treasury, Legal, Foreign Exchange, Fixed Assets, Direct and Indirect Tax and Information Technology General Controls (ITGC).
Control owners conduct self-assessment certi cation of controls through a veri able and transparent process and such certi cation is reinforced by activity and location owners, as they give in-principle approval for the self-assessment by the control owners. The result of the Controls Manager certi cation is prepared and presented to the audit committee quarterly by the Chief Financial Of cer (CFO) for review of exceptions.
Controls certi cation is also being validated by the in-house team through a review of the assertions certi ed by the Control Owners on a sample basis regularly across business units, plants, branches and corporate of ce. The policies are periodically reviewed and refreshed in line with the changes in business and regulatory requirements.
The audit committee, on a quarterly and annual basis, reviews the adequacy and effectiveness of the internal controls being exercised by various business and support functions.
Prevention and Detection of Frauds and Errors
Due to the presence of a strong Code of Conduct and Whistle Blower policy, it is generally expected that serious fraud will not take place. To prevent and detect frauds and errors, Deloitte Touche Tohmatsu India LLP (Deloitte) internal auditors carry out internal audit activity. Action points and suggestions made by them are discussed in sub-audit committee meetings before being presented to the audit committee. Subsequently, follow-up audits are also conducted by an in-house internal audit team or internal auditors to ensure the implementation of the suggestions. Additionally, special audits are performed by an in-house internal audit team or internal auditors in areas that may be vulnerable to fraud.
Accuracy and Completeness of the Accounting Records and Timely Preparation of Reliable Financial Information
Financial consolidation is carried out through an Enterprise Resource Planning system called Hyperion, thereby minimising the chances of manual errors. The
nancial information is veri ed by the statutory auditors periodically as per the requirements of the Companies Act, 2013, Securities and Exchange Board of India (SEBI) (Listing Obligations and Disclosure Requirements) Regulations, 2015 (the Listing Regulations), Institute of Chartered Accountants of India (ICAI) guidelines, etc. The Company provides structured training to its accounts and nance team on a wide range of topics, covering Indian Accounting Standards (Ind AS), International
Internal Control Systems and Risk Management
Risk-taking is an inherent trait of any enterprise. It is essential for the growth or creation of value in a company. At the same time, risks must be appropriately managed and controlled, enabling a company to achieve its objectives effectively and ef ciently.
Internal Financial Control Framework
Section 134(5)(e) of the Companies Act 2013 requires a company to lay down the Internal Financial Controls (IFC) system and to ensure that it is adequate and operating effectively. Internal Financial Controls are the policies and procedures adopted to ensure the orderly and ef cient conduct of business. The above requirement has the following elements:
Orderly and ef cient conduct of the business.
Safeguarding of assets.
Adherence to Companys policies. Prevention and detection of frauds and errors.
Accuracy and completeness of the accounting records and timely preparation of reliable nancial information.
Financial Reporting Standards (IFRS), the Companies Act, 2013, Direct and Indirect taxes among others, through in-house and external experts.
Implementation of Internal Financial Controls
To compete globally, the Company requires world-class Corporate
Governance and effective nancial control over its operations. The Internal Financial Controls, as mandated by the Companies Act, not only requires a certi cation from the Chief Executive Of cer (CEO) and Chief Financial Of cer
(CFO) but also puts an obligation on the Board of Directors to ensure that the Internal Financial Controls are adequate and are operating effectively. Besides this, the statutory auditors are also required to give an opinion on the adequacy and effectiveness of Internal Controls over Financial Reporting (ICFR).
To make the Internal Financial Controls framework robust, we have worked on three lines of defence strategy, which are as follows:
First Line of Defence: Build internal controls into operating processes - to this end, we have ensured that a detailed Delegation of Authority is issued, Standard Operating Procedures (SOPs) for the processes are created, nancial decision-making is done through Committees, IT controls are built into the processes, segregation of duties is done, strong budgetary control framework exists, the entity level controls including Code of Conduct, Ombudsperson of ce etc. are established.
Second Line of Defence: Create an ef cient review mechanism - we created a review mechanism under which all business units and functions are assessed for performance at least once a month by their respective
Chief Executive Of cers (CEOs) and once a quarter by the corporate team. The formats for these reviews are detailed and nalised with the help of global consulting rms.
Third Line of Defence: Independent assurance - we have appointed a Big Four
rm as our internal auditor to perform a systematic, independent audit of every aspect of the business to provide independent assurance on the effectiveness of the internal controls and highlight the gaps for continuous improvement.
A program has been developed under which more than 1,500 nancial controls have been established and certi ed on a quarterly basis by the relevant process owners before the nancial results are closed for the quarter. A quarterly certi cation process is maintained through a workflow-based IT tool called Controls Manager and this certi cation is the basis of the CEO-CFO certi cation of internal controls as per
Regulation 17(8) of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 (the Listing Regulations).
The Company regularly updates the control library and Risk & Control Matrices.
To enhance operational controls, we have established, for each line of business, a concept of nancial decision-making through operational committees. The entire purchase, credit control and capital expenditure decisions are taken jointly in committees. The key roles of these business committees are as follows: Supply Chain Committee, which ensures high-quality purchases at an economical cost and maintains the reliability of supplies from reputed suppliers with long-term relationships. This committee includes CEO, Head of Finance & Head of Supply Chain.
Capex Committee, which ensures cost reduction with proper negotiation and monitors time and cost overrun. This committee includes the CEO, Head of Finance, Head of Project & Head of Supply Chain.
Credit Committee, which evaluates the credit risk and approves the maximum credit which can be provided to a customer. This committee approves the credit limits at the beginning of the year and is empowered to make changes as and when required. This committee includes the CEO and Head of Finance.
Business Performance Committee, which reviews the business performance monthly. This committee includes the CEO, Head of Finance and Functional Heads.
In addition, to maintain periodic review and control, we have structured weekly meetings between the corporate team and the business leadership team. Through this meeting, the corporate team stays informed about the latest business developments and guides the business team to undertake mid-course corrections, if necessary. This meeting also provides a forum for obtaining the relevant approvals required from the corporate team as per Delegation of Authority. Participants at this meeting are Chairmen MD from the corporate side and CEOs, Business Head of Finance & Head FP&A.
Further, a detailed quarterly review of the business performance with the Chairmen MD and the corporate committee is organised to identify any gaps in performance and to consider mid-course corrections.
Risk Management Vision
To establish and maintain enterprise-wide risk management capabilities for active monitoring and mitigation of organisational risks on a continuous and sustainable basis.
Risk Management Strategy
We have formed a strong risk management framework that enables regular and active monitoring of business activities, for the identi cation, assessment and mitigation of potential internal or external risks. We have established processes and guidelines, along with a strong overview and monitoring system at the Board and senior management levels. Our senior management team sets the overall tone for risk minimisation culture through de ned and communicated corporate values, clearly assigned risk mitigation responsibilities and appropriately delegated authority. We have laid down procedures to inform Board members about the risk assessment and risk minimisation procedures. As an organisation, we promote strong ethical values and high levels of integrity in all our activities, which, in itself, signi cantly mitigates risk.
Risk Management Structure
Our risk management structure comprises the Board of Directors, the Risk Management Committee and the Audit Committee at the apex level, supported by CEOs and the Head of the Management Assurance function. As risk owners, the heads are entrusted with the responsibility of identi cation and monitoring of risks. These are then discussed and deliberated at various review forums chaired by the CEOs and actions are drawn upon. Progress against the risk management plan is periodically monitored. The Risk Management Committee, Audit Committee, CEOs and Head of Management Assurance act as a governing body to monitor the effectiveness of the Risk Management and Internal Financial Controls framework.
Risk Mitigation Methodology
We have in place a comprehensive internal audit plan and a robust Enterprise Risk Management (ERM) exercise, which helps identify risks at an early stage and take appropriate steps to mitigate them.
Each business head updates the risk register and identi es the top risks for the business. The Risk Head then consolidates top risks and reports them periodically to the Risk Management Committee, along with a mitigation plan.
We have a quarterly certi cation process wherein, the concerned control process owners certify the correctness of entity-level and process-level controls. The certi cation process has been in operation for over ten years and covers over 1,500 controls. The process-level controls cover a wide variety of key operating, nancial and compliance-related areas while entity-level controls cover integrity and ethical values, adequacy of audit and control mechanisms and effectiveness of internal and external communication, thereby, strengthening the internal
nancial control systems and processes with clear documentation on key control points. This has made our internal controls and processes stronger and serves as the basis for compliance with the provisions of the Listing Regulations.
Managements Assessment of Risk
The Company identi es and evaluates several risk factors and draws out appropriate mitigation plans associated with them. Some of the key risks affecting its businesses are laid out below:
1. cGMP Compliance Risk
As a pharmaceutical manufacturer, we operate in a highly regulated environment and are committed to maintaining full compliance with the stringent requirements of the U.S. Food and Drug Administration (FDA) and various international regulatory authorities. Our manufacturing facilities adhere to current Good Manufacturing Practices (cGMP), ensuring the highest standards of quality and safety.
Radiopharma Operations
Our Radiopharma division operates 45 nuclear pharmacies, including three Positron Emission Tomography (PET) drug manufacturing facilities across 22 U.S. states. These open formulary pharmacies provide clinicians with a broad range of radiopharmaceutical options, enabling optimal patient care. We maintain full compliance with State Boards of Pharmacy (BOP) and USP compounding standards, reinforcing our reputation for reliability and quality.
In March 2024, the FDA inspected our Orlando Radiopharmacy, resulting in six observations. We promptly submitted comprehensive corrective action plans and the FDA subsequently classi ed the inspection as Voluntary Action Indicated (VAI), con rming the sites compliance with cGMP.
The regulatory landscape for radiopharmacies is continually evolving. We have proactively aligned our operations with the FDAs Insanitary Conditions at Compounding Facilities guidance and USP <825> standards. In anticipation of revisions to 21 CFR 212, we are conducting a comprehensive gap assessment across our PET sites to ensure readiness and continued compliance.
In April 2024, the FDA inspected our Radiopharmaceutical manufacturing facility at Montreal, resulting in 5 observations. We promptly submitted comprehensive corrective action plans and the FDA subsequently classi ed the inspection as Voluntary Action Indicated (VAI), con rming the sites compliance with cGMP.
Contract Manufacturing and Allergy Business Units
Our Spokane facility, supporting both Contract Manufacturing Organisation (CMO) and Allergy business units, underwent inspections by the FDAs Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). The CBER inspection concluded with no observations (No Action Indicated ? NAI), while the CDER inspection resulted in a few observations, all of which were addressed through corrective actions. The inspection was closed with a VAI classi cation, con rming compliance with cGMP.
CMO Montreal Facility
In January 2024, Health Canada inspected our Montreal facility, issuing a Compliant GMP rating with no critical observations. A subsequent FDA inspection in June 2024 resulted in 15 observations and an Of cial Action Indicated (OAI) classi cation. To date, over 98% of corrective and preventive actions have been completed, with nearly 95% of actions under a comprehensive Quality Enhancement
Plan also nalised.
Solid Dosage Facilities
Our Roorkee, India facility, which manufactures solid dosage pharmaceutical products, was inspected by the U.S. Food and Drug Administration (FDA) in January 2024. Following four observations, we implemented prompt corrective actions and the FDA classi ed the inspection as VAI in April 2024. The site also underwent inspections by the EU and TGA, both of which concluded with no critical observations. The facility has received an EU GMP compliance certi cate.
Additionally, our Salisbury, Maryland, solid dosage facility was inspected by the FDA in January 2025 and received a VAI classi cation. Both facilities are currently in compliance with current Good Manufacturing Practice (cGMP) standards.
CRDMO Operations
Our Contract Research, Development and Manufacturing Organisation (CRDMO) business adheres to diverse international regulatory frameworks. The FDA inspected our Nanjangud API facility in December 2022, resulting in a Voluntary Action Indicated (VAI) classi cation. Subsequent inspections by Australias TGA (October 2023) and Brazils ANVISA (2024) concluded with no critical observations and a GMP-compliant rating, respectively.
Risk Mitigation Plan
We remain steadfast in our commitment to quality, safety and regulatory excellence through the following initiatives:
Process Optimisation: Leveraging automation, timely workforce training and robust Standard Operating Procedures (SOPs) to enhance operational ef ciency.
uality System Harmonisation:
Continuously re ning our quality systems to align with evolving global regulatory standards.
Investment in Innovation:
Advancing our capabilities through strategic investments in technology, infrastructure and talent development.
Our proactive approach to compliance and continuous improvement underscores our position as a trusted partner in the global pharmaceutical landscape.
2. Information Security Risk
Today, Information Technology has become the backbone of any business. A robust
Information Security strategy that includes con dentiality, integrity and availability of data at all times is key to achieving our business objectives. The occurrence of any unforeseen threats to information & technology systems could have an adverse impact on data availability and the continuity of business operations. Our systems may be the target of malware and other cyberattacks.
Risk Mitigation Plan
Our Information security framework is certi ed for ISO/IEC 27001 Standards, which ensures that all the information assets are adequately safeguarded. The Disaster Recovery (DR) site has been set up on the cloud and has been tested periodically.
There is an information security steering committee at the apex level, which gives directions and resources to manage the information security of the Company. All the security events affecting critical IT systems & data are being logged and monitored round the clock by our Next Gen Security Operations Centre (NGSOC).
Most of the Information assets are hosted in the ISO certi ed data centres or the cloud, which are subject to appropriate physical and logical access controls.
Requisite redundancies have been built within the IT infrastructure to ensure availability of information at all times.
We also publish an information security newsletter to raise end-user awareness about cybersecurity risks and mitigation strategies. White papers and other relevant articles are circulated to all users.
During the reporting period, the Company strengthened its cybersecurity controls and focused on enabling swift action on risks emerging across the businesses.
Jubilant Pharmova Limited has deployed specialised technical controls to protect from Ransomware attacks.
3. Decline in Financial & Operational performance
The Company has long-term liabilities that require it to comply with certain nancial covenants. In the event of any signi cant decline in the Companys operational and nancial performance, there may be a situation where the Company is not able to comply with those nancial covenants.
Risk Mitigation Plan
Multiple steps are being taken to improve the revenue, margin and earnings of the businesses: Entry into new geographies for the existing products.
Improving operating ef ciencies and through cost optimisations. The Company is taking several steps to improve its nancial performance, which will lead to a substantial improvement in both operational and
nancial performance.
4. Dependence on Certain Key Products and Customer Risk
The Company depends on certain key products and key long-term contracts with customers for a signi cant portion of its total revenue and any events that adversely affect the markets for key products or key contracts may adversely affect its nancial condition, results of operations and pro tability.
Risk Mitigation Plan
Our R&D team has taken a proactive approach to introduce new products, by deploying various technological platforms and capabilities. New products continue to get developed by experienced and talented R&D teams in line with market demand. We continue to sharpen Customer Relationship Management (CRM) and secure long-term contracts with our customers. Our business team focuses on identifying new pro table markets or increasing the share of business in existing markets.
5. Tariff Risk and Trade Risk
The Company operates in a global environment and is exposed to risks arising from international trade policies, including tariffs, duties and other trade barriers. Ongoing geopolitical tensions and evolving trade relationships between major economies have led to increased uncertainty in global trade dynamics. These developments pose potential risks to the Companys supply chain, cost structure and market access.
Tariff Risk: The imposition of new tariffs or changes to existing tariff structures on raw materials, active pharmaceutical ingredients (APIs), or
nished pharmaceutical products can signi cantly impact the Companys cost of goods sold. For example, tariffs on imports from key manufacturing hubs, such as China or India, may lead to increased input costs, which could affect pricing strategies and pro t margins.
Additionally, retaliatory tariffs imposed by other countries on pharmaceutical exports may limit the Companys ability to compete in certain international markets.
Trade Risk: Trade restrictions, export controls and non-tariff barriers such as regulatory misalignments or customs delays can disrupt the timely movement of goods across borders. These risks are particularly critical for the pharmaceutical industry, where product shelf life, regulatory compliance and timely delivery are essential. The Companys reliance on a globally distributed supply chain for sourcing raw materials and manufacturing intermediates further ampli es exposure to trade-related disruptions.
Risk Mitigation Plan
Goods from Canada (Radiopharmaceuticals) to US are exempted from tariffs under US ? Canada ? Mexico trade agreement.
The Company actively monitors global trade developments and engages with industry associations and regulatory bodies to advocate for stable and transparent trade policies. Strategic initiatives include diversifying the supplier base across multiple geographies, increasing local sourcing where feasible and maintaining buffer inventories for critical inputs.
The Company also evaluates the nancial impact of potential tariff changes through scenario planning and incorporates flexibility into its supply chain and pricing models.
6. Dependence on Single Manufacturing Facility Risk
Some of our products are manufactured at a single facility. For instance, Allergy products are solely produced by the manufacturing facility of Jubilant HollisterStier LLC in Spokane. The manufacturing facility of Jubilant Draxlmage Inc. in Montreal, Canada, solely produces radiopharmaceutical products. Similarly, the manufacturing facility in Nanjangud, India, is the sole manufacturing facility for APls.
Risk Mitigation Plan
Though our businesses are fairly diversi ed, however, we are exploring options for diversifying the manufacturing presence for our products, which are currently produced by a single manufacturing facility.
Furthermore, the Company is working on developing an alternative manufacturing site for its radiopharmaceuticals products through technology transfer.
7. Supply Chain Disruption Due to Few Suppliers Risk
In our Radiopharma, Generics and API businesses, for some of our key raw materials, we have only a single or a few external sources of supply and alternative sources may not be readily available.
Risk Mitigation Plan
We have an effective strategy to mitigate these risks by continuously developing alternative suppliers, which minimises any order cancellations. The Company is able to de-risk and signi cantly reduce the percentage of single-source value during the last nancial year.
We have established long-term supply arrangements with suppliers to ensure uninterrupted material availability.
8. Human Resources - Acquire and Retain Talent Risk
Given the nature and complexity of the pharmaceutical industrys regulatory regime, it is imperative that we recruit and retain high-quality personnel. Lack of credible, talented successors or effective knowledge transition mechanisms may adversely impact operations.
Risk Mitigation Plan
As a part of our strategic talent and succession management process, the leadership invests valuable time in identifying high-potential candidates and planning their development for succession to critical positions.
We conduct the leadership development program and the 360-degree feedback mechanism for these employees based on the leadership competency framework. Management employees at critical positions enrol in customised general management programs at premier institutes to prepare for larger roles and build cross-functional capability in the organisation.
We have launched a Learning Management System (LMS), which comprises an extensive collection of training and learning resources and can be accessed by all employees through the online portal.
Cultural change initiative continues with a focus on employee retention program and transparent communication with employees.
We conduct regular communication forums in the form of town halls, skip-level meetings and new joiner assimilation programs to understand employee concerns and a structured mitigation process is developed for effective redressal.
We ensure that there is complete adherence to the Code of Conduct and that fair business practices are followed.
9. Compliance and Regulatory Risk
Our business operates within a highly regulated environment and regulatory affairs play a vital role in the development of all businesses. Due to constantly increasing regulatory obligations as well as the globalisation of the market, the demands and responsibilities of businesses in terms of regulatory readiness are becoming stringent. We deal with various international regulatory agencies like the US FDA, EU agencies, Australian agency and Canadian agencies, the World Health Organisation (WHO), the Central Drugs Standard Control Organisation (CDSCO), India and various other international regulatory agencies in different parts of the world pertaining to drug substances and drug products.
Risk Mitigation Plan
We have put in place a compliance management system to ensure compliance with all applicable laws and regulations.
We have a dedicated team of experts whose knowledge ensures that global regulatory compliances are met and we can build competitive advantage. We also undertake training and orientation programs to keep the relevant process owners updated on new regulations and changes in the existing laws.
10. Competition, Cost
Competitiveness and Pricing Risk
Being a global manufacturer, the Company is exposed to pricing risk both as a buyer and seller. Concentration of raw material procurement to a few suppliers may lead to unfavourable and unethical price setting by suppliers, thereby eroding nancial margins and affecting competitiveness.
The competition faced by our different business segments is described in detail below:
Radiopharma and Allergy Immunotherapy
Many of our competitors have substantially greater experience in the development and marketing of branded,
& Analysis
innovative and consumer-oriented products. There is also a risk of the introduction of generic versions when our proprietary products lose their patent protection. There could be new entrants into a Generics market, where we are already a participant. Additionally,, distributors of our products may attempt to shift end-users to competing diagnostic modalities and products. Our current or future radiopharmaceutical products could become obsolete or uneconomical due to these activities.
Risk Mitigation Plan
We aim to differentiate through new product development, targeted formulation, improvement in our service quality as well as superior technical expertise.
CDMO Sterile Injectables
Contract Manufacturing is an operations-oriented business that requires cost and quality leadership, as well as robust business development. There is a risk that a new entrant or an existing competitor may accept operating at a lower margin or resort to penetration pricing in order to gain market share and develop key customer relationships. Our competitors may succeed in developing technologies, processes and products that are more cost-effective than we may develop or manufacture.
Risk Mitigation Plan
To mitigate this risk, the Company has initiated various programs to improve ef ciency and reduce costs by coordinating the efforts of different functions.
Several initiatives are currently under implementation towards cost improvement for existing projects.
Generics
Pricing pressure could arise from competitive products being introduced into a particular product market, price reductions by competitors, the ability of competitors to capitalise on their economies of scale to create excess product supply, the ability of competitors to produce or otherwise secure APls at lower costs than what we are required to pay to our suppliers.
Risk Mitigation Plan
Increasing penetration in other geographical regions.
Introducing cost improvement initiatives and manufacturing ef ciency improvement plans at plants by undertaking projects under Business Excellence programs. Signi cant steps have been taken to improve raw material and utilities consumption and increase manufacturing ef ciency.
Building long-term relationships with key customers by offering improved quality and service experience.
Building economies of scale in manufacturing, distribution channels and procurement to maintain cost advantage and sustained entry barrier. Developing external manufacturing facilities to make the products expeditiously and at a lower cost.
Contract Research, Development & Manufacturing Organisation (CRDMO) Drug Discovery Services
In the Drug Discovery Services area, demand for Clinical Research Organisation (CRO) services has slowed down in the past due to reduced funding in the Biotech market. This may result in higher contract terminations or non-renewals of existing contracts. The inability to fully cover the available capacity may occur. Additionally, the pharmaceutical industry is facing signi cant challenges, such as escalating cost of R&D, patent expirations, pricing pressure, increased regulatory and safety hurdles as well as lower productivity. A further risk in this business is the intrinsic discovery and development risk when programs fail to meet ef cacy, which leads to the suspension of efforts and a short-term decline in revenue until compensatory programs are developed.
Risk Mitigation Plan
To mitigate this risk, we are strengthening the sales team, penetrating the large pharma or large deal market, increasing scienti c and technological differentiation by creating ve centres of excellence, investing in high-end technology. Additionally, we continually review our internal processes and organisational structure to ensure higher ef ciency, increased scienti c output and cost-effectiveness.
We have added capability in Biologics through a strategic partnership with Pierre Fabre, France. This has enhanced our footprint in the EU.
CDMO-API
There is an intense competition in the market for APls. We need to identify and partner with a generic drug manufacturer that will use our APls in their formulation or wait for our solid dosage formulations to receive the requisite approvals. The regulatory approval process for new suppliers of APIs to generic manufacturers imposes signi cant timing constraints in bringing products to market.
Risk Mitigation Plan
For some of our generic formulations, we have captive manufacturing of APls to ensure timely material availability and effective cost control to focus on improving pro t margins.
Alternate sourcing of Key Starting Material (KSM) is being initiated. This will not only de-risk Chinas dependency but will also help in cost reduction of the nished products.
Proprietary Novel Drugs
In the Proprietary Novel Drugs segment, we face signi cant competition in an environment of rapid technological and scienti c change and our failure to effectively compete may prevent us from achieving signi cant market penetration.
Risk Mitigation Plan
Our precision medicine target and biomarker discovery platform and our scienti c and technical know-how give us a competitive advantage in this space, though competition from many sources remains.
11. Capacity Planning and Optimisation Risk
Our production capacity may not be aligned with market demand. Insuf cient capacity threatens our ability to meet demand and be competitive and excess capacity threatens the organisations ability to generate competitive pro t margins.
Risk Mitigation Plan
The Company continues to invest in the optimisation of our manufacturing capacity utilisation. Such optimisation is driven by continuous de-bottlenecking of our manufacturing plants and by value engineering through the application of Six Sigma, Lean Sigma and other value-added tools for productivity enhancement. To cater for the increasing demand, capacity expansion is being done at our Spokane and Montreal facilities to double sterile ll and nish capacity from current levels.
The business teams regularly track the trends for each product to ensure that there is suf cient capacity to meet demand.
We periodically undertake other initiatives to improve ef ciency in terms of throughput and cost reduction and to build additional capacities without committing signi cant capital outlay, thereby generating a better return on investment.
We have developed a dedicated external manufacturing team, which can help to outsource some capacities and capabilities in order to ensure quicker response to unforeseen market demand.
12. Ageing Machinery and Plant Risk
As a plants processes and associated equipment have a de nite service life, the changes in operating regimes increase loads on equipment and the integrity and reliability of equipment can be adversely affected. Regular capital expenditures (capex) for the upgradation of ageing manufacturing lines and equipment are required, along with adherence to preventive maintenance programs.
Risk Mitigation Plan
The Company continue to assess old equipment with regard to upgradation or replacement and undertakes appropriate Capital expenditure.
Reliability Program identi es equipment approaching the end of life. Equipments are managed through all stages of the life cycle, which includes detection, evaluation and necessary corrective actions to keep production, utility and support systems resilient for the intended service.
13. Research and Development (R&D) Effectiveness Risk
As a pharmaceutical manufacturer, our business growth is dependent on the successful execution of our R&D strategy. Our R&D is focused on developing commercially viable and sustainable new products, enhancing our existing products and implementing process improvements that enhance time, quality and cost ef ciency.
Risk Mitigation Plan
The Generics business had recalibrated its R&D strategy, to deliver innovative, high-quality products for various markets continually. The new strategy leverages a variety of product opportunities through in-licensing andor external product development in collaboration with specialised CROs. This is expected to accelerate product introduction as well as deliver the products to harness opportunities in a timely and cost-effective manner. We have an effective strategy to mitigate potential risks and ensure R&D effectiveness with earmarked budgets and investments in R&D commensurate with the business plans. We routinely evaluate and prioritise our R&D programs based on market dynamics and commercial viability.
We are continuously engaged in the development of new products for the pipeline of products that can be introduced in future.
The focus is on the development of processes within the deadlines at optimum cost with effective and ef cient scalability.
14. Environmental, Health and Safety:
The Companys operations span multiple geographical regions and are subject to a diverse range of EHS laws and regulations. Furthermore, the absence of a response plan or delays in response may adversely affect the business in the event of both anticipated and unanticipated disruptions due to internal and external factors related to Environment, Health and Safety.
Risk Mitigation Plan
The company has developed and deployed an EHS management system, which provides the structure for implementing proactive risk management solutions to ensure the safety of our people, ensure compliance with internal and external requirements, drive continuous improvement and support the overall strategy to operate in a safe and sustainable environment.
We have regularly made investments for the upgradation of process safety and enhanced process controls at our facilities.
Hazard Identi cation and Risk Study are conducted as and when required and corrective actions are monitored for implementation.
We continue to engage external subject matter experts to assess our operations and we jointly work with the help of their expertise to enhance our risk reduction efforts.
15. Protecting Intellectual Property Rights (IPR) Risk
There has been substantial patent-related litigation in the pharmaceutical and medical device industries concerning the manufacture, use and sales of various products. We take all reasonable steps to ensure that our products do not infringe valid third-party IPRs. Any material litigation or other communication alleging such infringements could delay the sale of or prevent us from selling our products.
Risk Mitigation Plan
We protect our products with patents in major markets. Depending on the jurisdiction, patent protection may be available for individual active ingredients speci c compounds, formulations and combinations containing active ingredients; manufacturing processes intermediates useful in the manufacture of products and new uses for existing products.
The Company has led intellectual property applications in various countries for innovations. The Company has trademarks primarily in India, the US, Canada, Europe, Nigeria, South Africa, Mexico, Columbia, China and Australia.
Besides patents, the Company relies on trade secrets, know-how and other proprietary information and hence, our employees, vendors and suppliers sign con dentiality agreements.
We have a dedicated team of scientists whose primary task is to ensure that the products are manufactured using only non-infringing processes and that compliance requirements are met by reviewing and monitoring IPR issues continuously.
16. Failure to Supply to Customers Risk
In the Pharmaceuticals segment, if we are unable to supply our products to customers as per the agreed timelines or speci cations or other conditions, we may face penalties from our customers as per the terms of the agreement.
Risk Mitigation Plan
We ensure that such risks are monitored and mitigated on a continuous basis to avoid customer dissatisfaction, order cancellations and decreased revenues.
17. Changes in Tax Legislation Risk
The Companys activities are subject to taxation at various rates worldwide, computed in accordance with local legislation and practices. Actions by governments to increase tax rates or to impose additional taxes may reduce our pro tability.
Revisions to tax legislation or to its interpretation (whether with prospective or retrospective effect) may also affect our results and signi cant judgment is required in determining our provision for income taxes. Likewise, we are subject to audits by tax authorities in many jurisdictions. In such audits, our interpretation of tax legislation might be challenged and tax authorities in various jurisdictions may disagree with and subsequently challenge the amount of pro ts taxed in such jurisdictions.
Risk Mitigation Plan
We have a dedicated team of tax professionals whose primary task is to ensure that the tax liabilities are correctly computed and any revision in the tax legislation is monitored continuously.
18. Foreign Currency Exposure Risk
There has been signi cant movement in exchange rates over the past few years.
A growing proportion of our sales, particularly in the US, Canada and European countries, is recorded in local currencies, which exposes us to the direct risk of exchange rate fluctuations.
Risk Mitigation Plan
The Company did not use any derivative nancial instruments or other hedging techniques to cover its potential exposure since net foreign exchange exposure is not signi cant.
19. Climate Change Risk
Our operations are spread across multiple geographical regions, making them vulnerable to both physical and transitional risks associated with climate change. According to the Intergovernmental Panel on Climate Change (IPCC) and other global think tanks, such as the World Resources Institute (WRI) and ThinkHazard, there has been an increase in global temperature compared to pre-industrial levels. The associated events, such as changes in precipitation patterns, variability in weather patterns and rising sea levels, might have an impact on our operations and business.
Risk Mitigation Plan
We are focusing on decarbonising operations, reducing Greenhouse Gas (GHG) emissions and utilising renewable energy sources such as solar and wind. We are also focusing and allocating funds on energy ef ciency, resource ef ciency, green chemistry, low carbon technologies and the use of biomass as a fuel for addressing climate change and assessing physical climate risk for climate-proo ng assets.
20. Environmental, Social and Governance (ESG) Ratings Risk
With growing awareness and demand for climate action among consumers, ESG Performance is now more important than ever for businesses to thrive in the present and future-proof their operations. Investorscustomers look for ESG ratings before taking any decision related to investment, productservice agreement, acquisition, merger, issuing license to operate, etc. The risk of failing to meet benchmarked ESG performance might not only challenge regulatory frameworks but also alter relations with shareholders, investments, demand for products and services and reputation.
Risk Mitigation Plan
We are improving the capabilities and competencies of our personnel on ESG by imparting various trainings on different ESG standards, frameworks and policies.
The requirements of various ESG ratings were shared with concerned departments to allocate resources and strategise the proper implementation of the requirements of the rating organisation.
We are becoming signatories to different relevant standards and reporting frameworks and are keeping ourselves updated with the changing regulations and needs of our stakeholders.
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1860-267-3000 / 7039-050-000
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+91 9892691696
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