Glenmark Generics (GGL) US subsidiary has received ANDA approval from USFDA for Betamethasone Dipropionate cream, 0.05%(augmented) and will soon commence marketing and distribution of this product in the U.S. market.
Betamethasone Dipropionate is a high-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses and is the generic therapeutic equivalent of Diprolene AF cream marketed by schering.
This is the eighth steroidal dermatological product in the company's marketed product portfolio targeting an overall segment value of US$ 60 million. This recent approval aligns with Glenmarks strategy to continue strengthening its presence in this niche segment. Two ANDA approvals from the company's semi-solid pipeline were received in the last quarter - Mometasone Furoate cream 0.1% and Mometasone Furoate ointment 0.1%. These products will be manufactured at Glenmark's U.S. FDA approved state of the art semi-solid facility located in Baddi, India. GGL had earlier licensed the US marketing rights for a line of Clobetasol Propionate dermatology products that include - cream, emulsified cream, ointment, gel and topical solution through a US based pharmaceutical development company.
Glenmark's current portfolio consists of 34 products, translating to 126 SKUs, authorized for distribution in the U.S. marketplace. The company has over 35 ANDAs pending approval with the USFDA of which 20% fall within the dermatology segment. 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.
The company made this announcement during the trading hours today, 25 September 2008.
BSE tips
No comments:
Post a Comment