Zydus Lifesciences Ltd.

Zydus Lifesciences (including its subsidiaries/ affiliates, hereafter referred to as ‘Zydus’) 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 $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.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.