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Glenmark Generics receives final approval from USFDA for Rizatriptan Benzoate

02 Jan 2013 Evaluate

Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics has been granted final approval from the United States Food and Drug Administration (USFDA) for Rizatriptan Benzoate Tablets, its generic version of Merck’s Maxalt Tablets. The company has commenced shipping immediately upon approval.

The approval is for the 5 mg and 10 mg of Rizatriptan. According to IMS Health for the 12 month period ending Sept 2012, Rizatriptan Benzoate Tablets achieved sales of $333 million.

Glenmark’s current portfolio consists of 82 products authorized for distribution in the US, marketplace and 46 ANDA’s pending approval with the USFDA. Besides, the company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.

Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals (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.

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