Glenmark receives ANDA approval for sevelamer hydrochloride tablets

Glenmark Pharmaceuticals (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for sevelamer hydrochloride tablets, 400 mg and 800 mg, a generic version of Renagel tablets, 400 mg and 800 mg, of Genzyme Corporation.

Sevelamer is indicated to patients with severe kidney disease to lower high blood phosphorus levels

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 $ 102.1 million.

Glenmark’s current portfolio consists of 149 products authorised for distribution in the US marketplace and 53 ANDA’s pending approval with the US 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.