Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Riluzole Tablets, 50mg. The Company will commence shipping immediately. Riluzole is indicated for the treatment of amyotrophic lateral sclerosis. Based on IMS Health sales data for the 12 month period ending March 2013, Riluzole garnered sales of USD 64 million.Glenmark’s current portfolio consists of 86 products authorized for distribution in the U.S. marketplace and 52 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.
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 and developing an EU presence. 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 80 countries, including the US, various countries in the EU, South America and India.
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 and developing an EU presence. 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 80 countries, including the US, various countries in the EU, South America and India.
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