Claris Lifesciences Ltd Company Summary

Claris Lifesciences Ltd Summary

Claris Lifesciences Ltd is one of the largest sterile injectables pharmaceutical companies in India with a market presence in 76 countries worldwide. The company primarily manufactures and markets products across multiple markets, and therapeutic segments. Their products offering comprise 128 products across multiple markets and therapeutic areas. All of their products are off-patent products, a significant majority of which are capable of being directly injected into the body and are predominantly used in the treatment of critical illnesses.The companys products range across various therapeutic segments includes anaesthesia, critical care, anti-infectives, renal care, infusion therapy, enteral & parenteral nutrition and oncology. They offer injectables in various delivery systems, such as glass and plastic bottles, vials, ampoules, pre-filled syringes and non-PVC/PVC bags. Their customer base primarily includes government and private hospitals, aid agencies, and nursing homes.The company has five manufacturing facilities spread over a 78-acre campus located in Ahmedabad, India. Some of these facilities have been approved by foreign regulatory authorities including the USFDA, MHRA (UK), TGA (Australia), NAM (Finland), GCC FDCA (Gulf Co-operation Council including Saudi Arabia, U.A.E. and other countries in the Middle East), ANVISA (Brazil) and INVIMA (Colombia). The company has four subsidiaries in India and thirteen subsidiaries located in Brazil, the United States, Mauritius, Colombia, Venezuela, Indonesia, Mexico, Australia, the UK, Chile and the Philippines. Some of their subsidiaries act as importers for the companys products, store and distribute the products locally and are responsible for marketing, promotion, invoicing and collection activities locally. They also set up representative offices in Russia, Kazakhstan, Uzbekistan and Vietnam.The company adopts three different distribution models for the supply of their products across international markets. In certain countries, they register, import and store products as well as market them to customers through entities owned and controlled by them. In certain other countries, they partner with local distributors who import and distribute their products and, under their supervision, carry out marketing activities. In the rest of the countries, distributors and marketing partners are responsible for marketing their products.Claris Lifesciences Ltd was incorporated on July 19, 1994 as a public limited company with the name Oracle Laboratories Ltd. In May 28, 1998, the company changed their name to Core Laboratories Ltd as the company acted as the marketing and distribution agent for Core Healthcare Ltd at that time. In March 31, 1999, the name of the company was changed to Claris Lifesciences Ltd. In May 12, 1999, Nova Lifesciences Ltd was amalgamated with the company and all the assets, liabilities and business of Nova Lifesciences Ltd was transferred to the company with effect from the appointed date, October 1, 1997. In the year 1999, the company inaugurated their first international office in Brazil. In the year 2002, they commissioned their first manufacturing plant, Clarion I. Also, they received the WHO GMP certificate for their Clarion I facility. Since then, the company expanded their operations to four manufacturing facilities (Clarion I to IV). In the year 2003, their manufacturing facility was approved by INVIMA, Colombia.In the year 2004, the company started commercial production at their infusion manufacturing facility. In the year 2005, the companys injectable manufacturing facility was approved by the MHRA, UK. They received their first regulated market order from the Netherlands. Also, they filed six ANDAs with the USFDA during the year. In the year 2007, the USFDA granted approval for the companys sterile injectable manufacturing facility in Clarion I.In the year 2008, the company received approval for four ANDAs in the United States. They launched a range of infusion products in non-PVC bags in India. Also, they commenced their own sales and marketing activities in the USA. In March 2009, the company entered into a business arrangement with the Pfizer group of companies (Pfizer) with a view to strengthen their presence in regulated markets. In the year 2010, the company received a letter from the USFDA in relation to the registration of our aseptic manufacturing line. As of September 30, 2010, the company had a network of approximately 43 clearing and forwarding agents, 40 distributors, 16 consignee agents and 1,120 stockists in India, enabling them to reach a significant number of hospitals, institutions and doctors. Also, they had filed 280 applications for product registrations in regulated markets, including 36 applications in the United States, out of which they had obtained 145 product registrations, including 25 in the United States.The companys fifth manufacturing facility, Clarion V, is currently under construction and is expected to be operational by the third quarter of 2011. They plan to set up a new plant comprising a small volume parenterals line, a PVC bag line, a non-PVC bag line and a fat emulsion line.The company plans to set up a new manufacturing line for propofol and other fat emulsion products at our existing plant, Clarion IV. They also plan to construct a facility for research and development at their Clarion manufacturing facilities. The company plans to increase their presence in emerging markets, such as Brazil, Mexico, South Korea and Saudi Arabia. They also plan to establish their business presence in new emerging markets, such as China, Russia, Turkey, Egypt and Argentina.