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Glenmark gets ANDA approval for hydrocortisone valerate cream

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MUMBAI, India — Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for hydrocortisone valerate cream USP, 0.2%, a generic version of Westcort1 Cream, 0.2%, of Sun Pharmaceutical Industries Inc.

According to IQVIATM sales data for the 12-month period ending August 2018, the Westcort Cream, 0.2% market achieved annual sales of approximately $17.0 million.

Glenmark’s current portfolio consists of 139 products authorized for distribution in the U.S. marketplace and 60 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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