HomeGlenmark Generics recieves ANDA approval from the U.S. FDA for Alclometasone Dipropionate Cream
Date: 25 June 2009
Glenmark Generics Limited (GGL) has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Alclometasone Dipropionate Cream, 0.05% and will commence marketing and distribution of this product in the U.S. market immediately.
Alclometasone Dipropionate is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Glenmark’s product is the AB rated generic equivalent of GSK’s Aclovate® cream and will be manufactured at Glenmark’s U.S. FDA approved state of the art semi-solid facility located in Baddi, India. This product is targeted for a niche category in the dermatology segment and competition is limited.
Glenmark Generics Limited is authorized to market 11 topical semi-solids in the United States. This approval aligns with Glenmark’s strategy to continue building upon their established presence in the dermatology marketplace.
Glenmark’s current portfolio consists of over 40 products authorized for distribution in the U.S. marketplace. The Company has over 40 ANDA’s pending for approval with the U.S. FDA. 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. In December 2008, Glenmark bagged the prestigious SCRIP award for the “Best Pharma Company in the World – SME” and the “Best Company in Emerging Markets” at the SCRIP Awards 2008 in London. SCRIP is the leading pharmaceuticals magazine in the world.
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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