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Glenmark Generics receives ANDA approval for Mupirocin Calcium Cream

28 Jan 2013 Evaluate

Glenmark Generics Inc., USA, (GGI) the United States subsidiary of Glenmark Generics has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Mupirocin Calcium Cream USP, 2%. The company will commence shipping immediately. Based on IMS Health sales data for the 12 month period ending Sept 2012, Mupirocin Calcium Cream garnered sales of $56.5 million.

Mupirocin Calcium Cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 square cm in area) due to susceptible strains of S. aureus and S. pyogenes.

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, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

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