Glenmark Pharmaceuticals Receives ANDA Approval for Sevelamer Hydrochloride Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Sevelamer Hydrochloride Tablets, 400 mg and 800 mg, a generic version of Renagel Tablets, 400 mg and 800 mg, of Genzyme Corporation. According to IQVIATM sales data for the 12-month period ending December 2018, the Renagel Tablets, 400 mg and 800 mg market achieved annual sales of approximately USD 102.1 million. Glenmark’s current portfolio consists of 149 products authorized for distribution in the U.S. marketplace and 53 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. – Medical Buyer Bureau