Glenmark Pharma has received final approval for Colesevelam Hydrochloride tablets, 625 mg, the generic version of Daiichi Sankyo’s Welchol tablets, 625 mg, from the US health regulator.
In a filing to the BSE the company stated, “Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Colesevelam Hydrochloride tablets, 625 mg.”
Furthermore, the company’s current portfolio consists of 135 products authorized for distribution in the US market and 62 abbreviated new drug applications (ANDAs) which are pending for approval with the USFDA.
