Glenmark Pharma’s arm gets USFDA’s nod for Zolmitriptan

27 Sep 2011 Evaluate

Glenmark Pharmaceuticals subsidiary - Glenmark Generics has been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (USFDA) for Zolmitriptan, generic version of IPR’s migraine treatment Zomig tablets.

The tentative approval granted by the US FDA is for 2.5mg and 5mg tablets of Zolmitriptan and constitutes one of two tentative approvals granted for a generic version of the drug.

Glenmark’s current portfolio consists of 73 products authorized for distribution in the US marketplace and over 40 ANDA’s pending approval with the USFDA. 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 is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. It has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. 

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