Glenmark Pharmaceuticals’ arm gets USFDA approval for Montelukast Sodium tablets

Glenmark Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532296 | NSE: GLENMARK

28 Nov 2011 Evaluate

Glenmark Pharmaceuticals' - Glenmark Generics Incorporation, USA, (GGI) the US subsidiary of Glenmark Generics has been granted tentative approval from United States Food and Drug Administration (USFDA) for Montelukast Sodium 10 mg tablets, their generic version of Singulair tablets by Merck.

IMS Health has recorded sales of Singulair 10 mg tablets for the 12 month period ending September 2011, as $3.2 billion. Based on the tentative approval for Montelukast Sodium tablets, Glenmark Generics should be able to launch the product upon patent expiry in August 2012.

Singulair is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older, for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older.

Glenmark's current portfolio consists of 73 products authorized for distribution in the US marketplace. The company has over 40 ANDA's pending approval with the USFDA. 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 (GGL) is a subsidiary of Glenmark Pharmaceuticals (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries.

Glenmark Pharmaceuticals, a leader among the emerging market companies in drug discovery and development and most of its active substances in the pipeline are first-in-Class. Glenmark’s achievements over the year include a major deal with Sanofi in Crohn's disease, completing Phase II trials of its first novel product, crofelemer and demonstrated higher sales and profit growth.

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