MUMBAI, India — Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (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 U.S. market.

According to IQVIATM sales data for the 12 month period ending March 2018, the Welchol Tablets, 625 mg market2 achieved annual sales of approximately $519.9 million.

Glenmark’s current portfolio consists of 135 products authorized for distribution in the U.S. marketplace and 62 ANDA’s pending approval with the U.S. 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.