Glenmark gets US FDA approval for its Goa facility Source: IRIS (03 October 2005)
Glenmark (Q, N,C,F)* Pharmaceuticals Ltd has received US FDA approval for its solid dosage plant in Goa that manufactures formulations for the international regulated markets. In addition to that, the plant also has the distinction of obtaining CGMP approvals by two other international regulatory bodies, viz. Therapeutics Products Directorate, Canada [TPD] and Medicine Control Council, South Africa [MCC]. Glenmark has filed 7 ANDAs to date from this facility and has plans to file 13 more this financial year. In addition, the company signed two partnership agreements with US based companies, Interpharm Inc. and Konec Inc., for marketing their generic products Naproxen and Nitroglycerin in the US. Glenmark has commenced marketing these generic products through its front-end in the US market and has already locked-in and is supplying contracts amounting to a market share in excess of 15% of the US market. The company also entered an exclusive license agreement with InvaGen Inc. for marketing its anti-hypertensive agent, Fosinopril Sodium oral tablets [Monopril(r)], for the US market. Glenmark had purchased two ANDAs from Clonmel Healthcare Ltd. in FY 2005 and had signed a collaboration agreement with another Indian company, Shasun Chemicals and Drugs Ltd., for the joint development and marketing of 13 generic products in the US market. The Company also expects to have at least five products on the market before the end of this financial year. About Glenmark Glenmark Pharmaceuticals Limited is an emerging global, fully integrated, research-based pharmaceutical company headquartered in Mumbai, India. The Company has generic formulation and API business interests in over 70 countries across the world including the highly regulated markets of USA and Europe. The formulation business spans several product segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT and Diabetes. The Company in also engaged in cutting-edge research in discovering new molecules and runs discovery projects in the areas of inflammation [Asthma/COPD, etc] and metabolic disorders [Diabetes, Obesity, etc]. It recently announced the licensing of its first Asthma/COPD molecule, GRC 3886 [INN: 'Oglemilast'], to Forest Labs and Teijin Pharma for the North American and Japanese markets, respectively. This compound has subsequently completed Phase I clinical trials successfully and will be entering Phase II clinical trials in the US shortly. The Company has also filed its second lead GRC 8200, a DPP-IV inhibitor for Type II Diabetes, for Phase I clinical trials in the UK in September 2005.
