Zydus Lifesciences has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic version of Rifaximin tablets, used to treat irritable bowel syndrome with diarrhoea (IBS-D) in adults. The approval marks a key step in expanding the company’s footprint in the high-value gastrointestinal segment in the United States.

Key highlights

USFDA approval for IBS-D drug

• Zydus has received tentative approval to manufacture and market Rifaximin Tablets, 550 mg, in the US.

• The tablets are indicated for treating Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adult patients.

High market potential

• As per IQVIA MAT March 2025 data, the Rifaximin market in the US saw annual sales of USD 2.67 billion.

• This approval positions Zydus to eventually tap into a sizable therapeutic segment upon final approval and launch.

Stock market impact
Despite the news, shares of Zydus Lifesciences were trading slightly lower at Rs 926.05, down 0.41% on the BSE.Zydus latest USFDA approval for Rifaximin tablets adds to its growing US portfolio, especially in niche therapy areas like IBS-D. With a multi-billion dollar market in sight, the company is poised for stronger US presence pending final marketing clearance.