Glenmark receives ANDA approval for Colesevelam Hydrochloride Tablets

21 May 2018 Evaluate

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Colesevelam Hydrochloride Tablets, 625 mg, the generic version of Welchol Tablets, 625 mg, of Daiichi Sankyo. The company has already commenced supplies of the product to the US market.

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

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

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).

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