Zydus receives tentative USFDA approval for Rifaximin Tablets, 550 mg
By Aman Shukla Published on June 2, 2025, 08:12 IST
Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg.
The approved product is a generic version of Xifaxan® Tablets, 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be manufactured at the company's SEZ II facility in Ahmedabad, India.
According to IQVIA MAT data for March 2025, Rifaximin Tablets, 550 mg, recorded annual sales of approximately USD $2,672.9 million in the U.S. market.
With this tentative approval, Zydus now has a total of 427 ANDA approvals. Since beginning its ANDA filings in the financial year 2003–04, the company has submitted 492 ANDAs to date.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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