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Glenmark Pharmaceuticals receives tentative ANDA approval for generic version of Epiduo® Gel

 

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

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

Glenmark’s current portfolio consists of 112 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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