Glenmark bags another FDA approval

Glenmark Pharmaceuticals receives tentative ANDA approval for Adapalene and Benzoyl Peroxide Gel, 0.1 |2.5 percent

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Glenmark's drug is the generic version of Epiduo Gel of Galderma Laboratories

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Adapalene and Benzoyl Peroxide Gel, 0.1|2.5 percent, the generic version of Epiduo Gel of Galderma Laboratories LP.

According to IMS Health sales data for the 12 month period ending February 2016, the Epiduo Gel market1 achieved annual sales of approximately $351.8 million.

Glenmark's current portfolio consists of 112 products authorized for distribution in the US marketplace and 58 ANDA's pending approval with the FDA.

 

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