Zydus receives USFDA final approval to manufacture ulcer drug

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram.

According to the filing, Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. 

Further, the drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad (India).

Sucralfate Tablets USP, 1 gram had annual sales of USD 84 million in the United States (IQVIA MAT Feb. 2023).

Notably, the group now has 367 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.

Source: Media reports