Glenmark Generics Limited's (GGL) US subsidiary has received ANDA approval from the United States Food and Drug Administration (US FDA) for Betamethasone dipropionate cream, 0.05 per cent (augmented) and will soon commence marketing and distribution of this product in the US market.

Betamethasone dipropionate is a high-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive 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 per cent and Mometasone Furoate ointment 0.1 per cent. These products will be manufactured at Glenmark's US 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 US marketplace. The company has over 35 ANDA's pending approval with the US FDA of which 20 per cent 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.