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Biocon Pharma Limited Secures U.S. FDA Tentative Approval for Rifaximin Tablets in Partnership with Carnegie Pharmaceuticals

  • Tue, 07-Oct-2025
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

This is to inform you that Biocon Pharma Limited, a wholly owned subsidiary of the Company, in partnership with Carnegie Pharmaceuticals LLC, received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for the ANDA for Rifaximin Tablets, 550 mg.

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.


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Author: BIOCON

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