Glenmark Generics Ltd (GGL), a wholly owned subsidiary of Glenmark Pharmaceuticals, has received ANDA approval from the US FDA for Alclometasone Dipropionate cream, 0.05 per cent and will commence marketing and distribution of this product in the US 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 US 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.
GGL 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 US marketplace. The company has over 40 ANDA's pending for approval with the US 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.
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.