Glenmark Generics Inc, USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received ANDA approval from the United States Food and Drug Administration (US FDA) for Adapalene gel, 0.1% and will soon commence marketing and distribution of this product in the US market. The company anticipates a successful launch based on their semi-solid experience and the limited number of competitors in this market.
Adapalene gel is indicated for the topical treatment of acne vulgaris. Glenmark’s product is the AB rated generic equivalent of Galderma’s Differin gel which generated approximately USD 84 million in sales for the 12 month period ending March 2010, according to IMS Health.
This approval expands the volume of the company’s portfolio to include a total of 15 semi-solid products authorized for distribution.
Glenmark’s current portfolio consists of 55 products authorized for distribution in the US marketplace. The company has over 50 ANDA’s pending 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.