FilingReader Intelligence

Biocon subsidiary receives tentative FDA approval for rifaximin tablets

October 7, 2025 at 02:39 AM UTCBy FilingReader AI

Biocon Pharma Limited, a wholly owned subsidiary of Biocon, in partnership with Carnegie Pharmaceuticals LLC, has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. This development was announced in a notification to stock exchanges by Rajesh U. Shanoy, company secretary and compliance officer, dated October 07, 2025.

Rifaximin tablets, a rifamycin antibacterial, are indicated for two key therapeutic uses. Firstly, they are prescribed for reducing the risk of overt hepatic encephalopathy (HE) recurrence. Secondly, they are intended to treat irritable bowel syndrome with diarrhea (IBS-D) in adult patients. This tentative approval marks a crucial step toward potentially bringing this treatment to market.

The announcement underscores Biocon's continued efforts in expanding its product portfolio and addressing unmet medical needs.

This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com

BSE:BIOCONBombay Stock Exchange

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