HomeGlenmark receives ANDA approval from U.S. FDA for Hydralazine Hydrochloride Tablets
Date: 01 June 2009
Glenmark Generics Inc. USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received the final ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Hydralazine Hydrochloride Tablets. The product has been approved in the active strengths of 10 mg, 25mg, 50mg, and 100mg as the AB rated generic Pliva’s equivalent Hydralazine Hydrochloride.
Glenmark will immediately commence marketing and shipping their generic version of the four presentations in various sku’s within the U.S market. Hydralazine Hydrochloride tablets are indicated for the treatment of essential hypertension. IMS Health data for the 12 month period ending March 2009 showed total sales of over USD 55 million for Hydralazine Hydrochloride tablets with limited competition.
Glenmark’s current portfolio consists of 40 generic products authorized for distribution in the U.S. market. The Company currently has over 40 ANDA’s filed with the U.S. FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.
About Glenmark Generics Ltd.:Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. GGL has a strong base in Formulations development with teams operating out of laboratories in India and Latin America. The Company has a state-of-the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world and had over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs. [www.glenmark-generics.com]
About Glenmark Pharmaceuticals Ltd.:Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. The company is listed on India’s two premier stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5500 people across its global operations over 85 countries. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The Company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211 has been out-licensed to Eli Lilly & company.
For more information on GPL, log on to http://www.glenmarkpharma.com/
For further information, please contact:
Jason D’Souza | Medha Satam
Glenmark, Mumbai, India Tel: [+91 22] 40189919 / 40189993
Email : connect@glenmark-generics.com
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