Mumbai, May 21 (UNI) Pharma Major, Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Colesevelam Hydrochloride
Tablets, 625 mg, the generic version of Welchol Tablets, 625 mg, of Daiichi Sankyo Inc.
The company has already commenced supplies of the product to the US market, the company said in a filing with BSE.
According to IQVIATM sales data for the 12 month period ending March 2018, the Welchol Tablets, 625 mg market2 achieved annual sales of approximately USD519.9 million.
Glenmark's current portfolio consists of 135 products authorised for distribution in the U.S. marketplace and 62 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.
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