Zydus Life Gets USFDA Nod To Manufacture Market Ulcer Drug

The approval granted by the US Food and Drug Administration (USFDA) is to manufacture and market Sucralfate Tablets of strength 1 gram, Zydus Lifesciences said in a regulatory filing. The drug will be manufactured at the group's topical manufacturing facility at SEZ, Ahmedabad, it added. Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market sucralfate tablets used in the treatment and prevention of ulcers in the intestines.

The approval granted by the US Food and Drug Administration (USFDA) is to manufacture and market Sucralfate Tablets of strength 1 gram, Zydus Lifesciences said in a regulatory filing. The drug will be manufactured at the group's topical manufacturing facility at SEZ, Ahmedabad, it added. Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury, and thus helps ulcers heal more quickly, the company said. Sucralfate tablets 1 gram had annual sales of USD 84 million in the US, it said citing IQVIA MAT February 2023 data.