Glenmark Generics Inc. (GGI), USA the subsidiary of Glenmark Generics Limited (GGL), has been granted final Abbreviated New Drug Approval (ANDA) from the United States Food and Drug Administration (US FDA) for Mupirocin ointment USP, 2 per cent.
Mupirocin ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes and is available in a 22 gram tube presentation. Based on IMS Health sales data for the 12 month period ending March 2011, mupirocin ointment garnered annual sales of US$ 55 million and achieved a 9 per cent increase in growth compared to the same period last year.
Glenmark’s current portfolio consists of 68 products authorized for distribution in the US marketplace and 39 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.
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.