Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

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

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

Rifaximin tablets had annual sales of US$ 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.