Drug maker Glenmark Pharmaceuticals Inc., USA (Glenmark) on Monday said that, “it 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®1 Tablets, 400 mg and 800 mg, of Genzyme Corporation,” in a filing to Bombay Stock Exchange.
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,” the company said.
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.
The shares of the company were trading at 605.00 apiece, low at 9.45 points or 1.54 per cent at 11:55 hours on the BSE.