Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg.

Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets will be produced at the Group's manufacturing site at SEZ II, Ahmedabad, the company said in a statement.

Rifaximin tablets had annual sales of USD 2672.9 mn in the United States (IQVIA MAT March 2025).

The group now has 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04.