Friday, 26 April 2019

Glenmark receives ANDA approval for Sevelamer Hydrochloride Tablets

11 February 2019 | News

It is a generic version of Renagel Tablets, 400 mg and 800 mg, of Genzyme Corporation

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration 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 market2 achieved annual sales of approximately $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.

 

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