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Glenmark Generics receives ANDA approval for Mupirocin
Our Bureau, Mumbai | Monday, January 28, 2013, 13:15 Hrs  [IST]

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 (FDA) for Mupirocin calcium cream USP, two per cent. Glenmark will begin shipping of this product very soon. Mupirocin calcium cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes. Based on IMS Health sales data for the 12 months period ended September 2012, Mupirocin calcium cream garnered sales of US$ 56.5 million. Glenmark’s current portfolio consists of 83 products authorized for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark Generics 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 and the European Union, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 63 countries, including the US and various countries in the EU, South America and India.

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