Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (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 authorised for distribution in the US marketplace and 58 ANDA’s pending approval with the US 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.
Glenmark Pharmaceuticals Ltd (GPL) is a research-driven, global, integrated pharmaceutical organisation headquartered at Mumbai, India.