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Glenmark gets ANDA approval for Colesevelam Hydrochloride Tablets, 625 mg

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The company has already commenced supplies of the product to the US market

Glenmark Pharmaceuticals 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 1 Tablets, 625 mg, of Daiichi Sankyo.

Reportedly, the company has already commenced supplies of the product to the US market. According to IQVIATM sales data for the 12 month period ending March 2018, the Welchol Tablets, 625 mg market achieved annual sales of approximately $519.9 million*.

Glenmark’s current portfolio consists of 135 products authorised for distribution in the US marketplace and 62 ANDAs pending approval with the US FDA.

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