Glenmark Generics gets Tentative Approval for Montelukast Sodium 10 mg tablets from the USFDA

Date: 28 November 2011

Press Release

Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Ltd, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval 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 USD 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 U.S. marketplace. The Company has over 40 ANDA’s pending approval with the U.S. 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.

About Glenmark Generics Limited. Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (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. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.

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For further information, please contact: Jason D’Souza
Glenmark, Mumbai, India Tel: [+91 22] 40189919 Email : connect@glenmark-generics.com

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