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(02 Jun 2025, 10:47)

Zydus Lifesciences gets USFDA nod for Rifaximin tablets

Zydus Lifesciences announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin tablets, 550 mg, under the reference listed drug (RLD) Xifaxan tablets, 550 mg.


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

According to IQVIA MAT 2025, Rifaximin tablets had annual sales of USD $2,672.9 million in the United States.

The group now has 427 approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04.

The company’s consolidated net profit shed 0.96% to Rs 1,170.9 crore on 17.21% rise in revenue from operations to Rs 6290.2 crore in Q4 FY25 over Q4 FY24.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

Shares of Zydus Lifesciences shed 0.53% to Rs 924.95 on the BSE.

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