Glenmark receives ANDA approval for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5%

Glenmark has been granted final approval by the United States Food & Drug Administration (US FDA) for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5%, the generic version of Epiduo1 Gel, 0.1%|2.5%, of Galderma Laboratories.

According to IQVIATM sales data for the 12-month period ending September 2019, the Epiduo Gel, 0.1%|2.5% market achieved annual sales of approximately $33.7 million.

Glenmark’s current portfolio consists of 163 products authorised for distribution in the US marketplace and 45 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.