Glenmark Generics Inc USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received the final ANDA approval from the United States Food and Drug Administration (US FDA) for Hydralazine Hydrochloride tablets. The product has been approved in the active strengths of 10 mg, 25mg, 50mg, and 100mg as the AB rated generic Pliva's equivalent Hydralazine Hydrochloride. Glenmark will immediately commence marketing and shipping their generic version of the four presentations in various sku's within the US market.
Hydralazine Hydrochloride tablets are indicated for the treatment of essential hypertension. IMS Health data for the 12 month period ending March 2009 showed total sales of over USD 55 million for Hydralazine Hydrochloride tablets with limited competition.
Glenmark's current portfolio consists of 40 generic products authorized for distribution in the US market. The company currently has over 40 ANDA's filed with the US FDA pending approval. 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.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals Limited and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.