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Biocon Pharma Secures USFDA Nod for Rifaximin Tablets 550 mg

By Shishta Dutta | Published at: Oct 7, 2025 05:38 PM IST

Biocon Pharma Secures USFDA Nod for Rifaximin Tablets 550 mg
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Bengaluru, October 7, 2025: Biocon Limited (NSE: BIOCON, BSE: 532523), one of the leading pharmaceutical companies, has announced that its wholly owned subsidiary, Biocon Pharma Limited, has received a tentative approval from the USFDA (US Food and Drug Administration) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablet (550 mg). It will be manufactured in collaboration with Carnegie Pharmaceuticals LLC.

The drug under consideration is a rifamycin-class antibacterial, which has shown promise in reducing the risk of overt hepatic encephalopathy (HE) recurrence and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

The approval represents another step in Biocon’s growing presence in the U.S. generics market, particularly within the gastrointestinal therapeutics segment.

Stock Price Movement

Biocon Pharma shares experienced a volatile session, closing at ₹348.95, marking a 0.35% gain from the previous day’s close. Over the past six months, the stock has recorded a notable rise of approximately 16.42%. During the trading session, it touched an intraday high of ₹351.10 and a low of ₹346.90. The company’s price-to-earnings (PE) ratio stands at 120.57, significantly above the industry average of 34.33.

REF: https://nsearchives.nseindia.com/corporate/Biocon2_07102025080506_Notification_to_SE07102025.pdf

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