Zydus Lifesciences gets FDA final approval for Sucralfate Tablets

Zydus Lifesciences has bagged final approval to manufacture and market Sucralfate Tablets USP, 1 gram from the US Food and Drug Administration (FDA).

The approved product is the generic version of Carafate Tablets, 1 gram.

Sucralfate is indicated for the treatment and prevention of intestinal ulcers by creating a coating over ulcers and protecting the area from additional injury. This helps in the quick healing of the ulcers, said Zydus Lifesciences.

Zydus Lifesciences gets FDA final approval for Sucralfate Tablets. Photo courtesy of Zydus Cadila.

The Indian pharma company will manufacture Sucralfate Tablets at its topical manufacturing facility at SEZ, Ahmedabad.

As per IQVIA MAT February 2023, the annual sales of Sucralfate Tablets USP, 1 gram in the US was $84 million.

Zydus Lifesciences currently has 367 approvals and has to date submitted more than 440 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.