Glenmark Pharmaceuticals receives ANDA approval for Pimecrolimus Cream, 1%

Glenmark Pharmaceuticals receives ANDA approval for Pimecrolimus Cream, 1%

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Pimecrolimus Cream, 1%, a generic version of Elidel Cream, 1%, of Bausch Health US, LLC. According to IQVIATM sales data for the 12 month period ending July 2019, the Elidel Cream, 1% market2 achieved annual sales of approximately $198.8 million*.

Glenmark’s current portfolio consists of 160 products authorized for distribution in the U.S. marketplace and 55 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.