Zydus Lifesciences Gets Tentative USFDA Nod For Rifaximin Tablets

Zydus Lifesciences said Monday it has received tentative approval from the US Food and Drug Administration for its 550 mg Rifaximin tablets. The tablets will be manufactured at the group’s SEZ II site in Ahmedabad, according to the company’s exchange filing.

Rifaximin is used to treat irritable bowel syndrome with diarrhoea in adults. The drug recorded annual US sales of $2.67 billion, per IQVIA MAT’s March 2025 report.

Zydus now holds 427 approvals and has filed 492 abbreviated new drug applications since it began filing in 2003-04.