Glenmark Generics receives USFDA approval
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 Glenmark?s 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 ANDA?s
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.
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