HomeGlenmark Generics receives ANDA approval from the U.S. FDA for Alclometasone Dipropionate Ointment
Date: 31 July 2009
Glenmark Generics Limited (GGL) has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Alclometasone Dipropionate Ointment, 0.05% and will commence marketing and distribution of this product in the U.S. market immediately. In June’09, Glenmark received FDA approval for Alclometasone Dipropionate cream.
Today’s approval compliments Glenmark’s recent launch of Alclometasone Dipropionate Cream and allows the company to provide superior service to their customers by offering the complete line of Alclometasone topical products. Generic competition on these niche products are limited.
Alclometasone Dipropionate ointment 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® ointment.
Glenmark’s version of both the cream and ointment will be manufactured in its U.S. FDA approved, state of the art semi-solid facility located in Baddi, India. The Company is now authorized to market 12 topical semi-solids in the United States.
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 has over 30 USDMFs 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 the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The company has a significant presence in branded generics markets across emerging economies including India.
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. 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 / 40189993Email : connect@glenmark-generics.com
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