Pharmaceuticals firm Zydus Lifesciences Ltd on Thursday, May 4, said it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market sucralfate tablets USP, 1 gram.
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, the company said in an exchange filing
The drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad, the company said.
According to IQVIA MAT February 2023, sucralfate tablets USP, 1 gram had annual sales of $84 million in the United States.
As of December 31, 2022, 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.
