Pharmaceuticals Newsletter - January 2 to 6, 2017

India Infoline News Service | Mumbai | January 06, 2017 16:43 IST

This week, Natco Pharma received the US FDA nod for Generic Bendamustine HCL powder, while Lupin received the nod for generic Evoxac Capsules. IIFL presents a weekly snapshot of all the major happenings in the Pharmaceuticals industry.

Top News 

Natco Pharma receives US FDA nod for Generic Bendamustine HCL powder

Natco Pharma, a leading manufacturer of finished dosage formulations (FDFs) and active pharmaceutical ingredients (APIs) recently has received final US FDA nod for its generic version of Bendamustine Hydrochloride powder used in injections, 25mg/Vial and 100 mg/vial. Going forward the company has plans to launch Bendamustine in US on November 1, 2019 or earlier if possible. The company would launch the same through Breckenridge, its marketing partner in the US market. Currently, Cephalon powered by Teva, markets this Bendamustine Hydrochloride powder under the name Treanda in the US market. Read More 

Slayback Pharma announces $ 60 million in new financing by KKR
 
Slayback Pharma, LLC, a privately held pharmaceutical research and development company, announced the closing of a $ 60 million commitment by KKR, a leading global investment firm. The financing will help Slayback enhance and accelerate the development of its portfolio of complex generic and specialty pharmaceutical products. Read More

Lupin receives FDA nod for generic Evoxac Capsules
Pharma Major Lupin Limited has received final approval for its Cevimeline Hydrochloride Capsules, 30 mg from the United States Food and Drug Administration (FDA) to market a generic version of Daiichi Sankyo Inc's Evoxac Capsules, 30 mg. Lupin shall commence promoting the product  shortly. Lupin's Cevimeline Hydrochloride Capsules, 30 mg are the AB rated generic equivalent of Daiichi Sankyo Inc's Evoxac Capsules, 30 mg. Cevimeline Hydrochloride Capsules, 30 mg are indicated for the treatment of symptoms of dry mouth in patients with Sjiigren's Syndrome. Read More

Natco launches Velpanat in Nepal
 Natco Pharma Limited announced that it has launched the first generic version of Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination in Nepal. Sofosbuvir 400mg/Velpatasvir 100mg fixed dose combination is sold by Gilead Sciences, Inc., under brand name Epclusa - the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Read More

Suven Life Science secures two product patents
Suven Life Sciences announced the grant of one (1) product patent from Eurasia (025136) and one (1) product patent from Norway (339034) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2032 and 2025 respectively. The granted claims of the patents are from the mechanism of action which include the class of selective H3 Inverse agonist compounds and 5HT6 compounds and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Major Depressive disorder (MDD), Parkinson and Schizophrenia. Read More

Domestic News

Panacea Biotec gains, owing to increased availability of life saving drug
Panacea Biotec, one of India’s leading research based Biotechnology company, has ensured increased availability of the life saving drug, Cilamin 250 (D-Penicillamine IP 250 mg) capsules for the treatment of Wilson’s disease in India. Cilamin 250 Capsule used for treatment of Wilson's disease, Rheumatoid Arthritis and other conditions, was witnessing short supply in the market during the last few months due to non-availability of raw material D-Penicillamine in India. Panacea Biotec has received additional quantity of raw material. Read More

Hikal sells property at raise funds for business operations
Hikal Ltd, a small-cap pharmaceutical company recently concluded the process of sale of its 1.52 acres Bangalore land. The land situated at Kalena Agrahara Village, Begur, Hobli, Bangalore was being used as an R&D centre. The sale proceeds will be used for company’s operations. Earlier in 2014 company had consolidated R&D operations at its fully equipped Pune site. Thereby, the Bangalore land was lying vacant with no productive operations since 2014. Read More

Jubilant Life gets a fresh lease of life; surges 3.7% on signing Radiopharma contracts
Jubilant Life Sciences, a global Pharma and Life Science company has duly signed a long-term contract in Radiopharma business with Montreal Canada for distribution of products used for diagnostic and therapeutic procedures for thyroid, myocardial perfusion, lung, kidney and bone scans. The company has entered into a contract through its subsidiary, Jubilant Pharma Limited.
The company already has a huge market in the US for its Draximage business and signing such long-term contracts would help it to increase its market share. Read More

Bafna Pharma to consider fresh issue of share warrants
Bafna Pharmaceuticals Ltd has stated that it would consider fresh issue of share warrants, prompting a jump in its stocks prices by 6%. A board meeting will be held today to consider withdrawal of entire preferential issue of 40,00,000 share warrants due to inordinate delay in the process. The meeting will also mull to propose and consider fresh issue of 80,00,000 share warrants to promoter and non-promoter groups subject to necessary approvals. Read More

Glenmark gets USFDA approval for capsules treating leukemia
Pharma major Glenmark Pharmaceuticals has received final approval from the US health regulator USFDA for sale of Tretinoin Capsules, used in treatment of leukemia. Read More

Wockhardt says no further updates required over US FDA's warning letter
Giving a clarification over US FDA's "warning letter" to Wockhardt on the its API (Active Pharmaceutical Ingredients) Unit in Ankleshwar in Gujarat, the company said that since the "Import Alert" by the US FDA had already been effected on the said unit of the company in August 2016 and the "warning letter" is a part of the same process of US FDA, and hence "no further updates in this context were required". Read More

Wockhardt gets a green signal for Gujarat facility: receives a EU GMP certificate
Wockhardt announced that it has received the EU GMP certificate from Berlin, Germany regarding the manufacturing facility at 138, GIDC Estate, Ankaleshwar Gujarat. Four to five facilities have been approved for pharmaceuticals' and APIs' production activities. Normally a compliance certificate is issued for 3 years. No specific observations have been received with the clearance certificate.
The certificate is issued for the unit which complies with the principles and guidelines of cGMP. The certificate issued is valid for 3 years.
Read More

Piramal’s subsidiary to incorporate a Housing Finance Company
Piramal Enterprises, a manufacturer and seller of own and traded bulk drugs and formulations, has announced that the company’s wholly owned subsidiary had made an application for incorporating a Housing Finance Company (HFC). Piramal Finance Limited, a subsidiary of Piramal Enterprises has made an application to National Housing Bank for incorporating an HFC as its subsidiary. The said has been approved by the company’s board of directors.
 

Advertisements

  • Save upto Rs.2.67 lakh with Pradhan Mantri Awas Yojana ...Know more
  • Now Save Rs.3150 on your Demat Account ...Click here
  • Now get IIFL Personal Loan in just 8* hours...APPLY NOW!
  • Get the most detailed result analysis on the web - Real Fast!
  • Actionable & Award-Winning Research on 500 Listed Indian Companies.