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11-Feb2019

Glenmark's arm gets approval from USFDA for Sevelamer Hydrochloride Tablets

Glenmark Pharmaceuticals – subsidiary -- Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) 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 IQVIA sales data for the 12 month period ending December 2018, the Renagel Tablets, 400 mg and 800 mg market achieved annual sales of approximately $102.1 million.

The company's current portfolio consists of 149 products authorized for distribution in the US market place and 53 ANDA's pending approval with the USFDA. 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 is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).


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