Glenmark gets ANDA approval from US FDA for generic betamethasone corticosteroid

Glenmark Generics Limited, a subsidiary of Glenmark Pharmaceuticals Limited has received ANDA approval from the US Food and Drug Administration (US FDA) for betamethasone dipropionate cream, 0.05 per cent (augmented), a corticosteroid which is the generic therapeutic equivalent of Diprolene AF cream marketed by Schering

Betamethasone bipropionate is a high-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The company will soon commence marketing and distribution of this product in the US market.

The recent approval is in line with the parent firm's strategy to continue strengthening its presence in this niche segment. This is the eighth steroidal dermatological product by the company with an overall segment value of $60 million.

In the last quarter two ANDA approvals for mometasone furoate cream 0.1 per cent and mometasone furoate ointment 0.1 per cent were received and these products will be manufactured at Glenmark's US FDA approved facility at Baddi, in Himachal Pradesh.

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, authorised for distribution in the US market. The company has over 35 ANDA's pending approval with the US FDA of which 20 per cent fall within the dermatology segment.

GGL has interest in integrated generic and active pharmaceutical ingredient and has established a presence in North America, EU and Argentina. Its manufacturing plant at Goa is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. It markets over 45 APIs to more than 80 countries across the world and has over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs.

GGL generated USD 196 Mn in Net Sales in FY08.