Glenmark Pharma’s US arm gets USFDA approval for Mupirocin ointment

10 Jun 2011 Evaluate

Glenmark Generics’ (GGL) United States (US) subsidiary -- Glenmark Generics Inc., (GGI) -- has been granted final approval for its Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (USFDA) for Mupirocin ointment USP, 2%.

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. Mupirocin ointment garnered annual sales of $55 million and achieved a 9% 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 and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries.

On consolidated basis, the group’s net profit after tax for the year ended March 31, 2011 increased marginally by 38.30% at Rs 457.83 crore as compared to Rs 331.03 crore for the previous year. Total income for the year increased by 21.93% at 3089.59 crore as compared to Rs 2533.81 crore for the previous year.

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