Zydus gains FDA approval for urinary tract infection medication 

Zydus Lifesciences Limited announced today it has received final approval from the US Food and Drug Administration (USFDA) to manufacture Methenamine Hippurate Tablets USP, 1 gram. The medication, which is the generic equivalent of Hiprex Tablets, is used for the prophylactic or suppressive treatment of frequently recurring urinary tract infections.

The shares of Zydus Lifesciences Limited were trading at ₹883.50 down by ₹16.35 or 1.82 per cent on the NSE today at 2.45 pm.

The tablets will be produced at Zydus Lifesciences’ facility in Ahmedabad, India. According to IQVIA data, the approved medication generated annual sales of $32.6 million in the United States as of January 2025.

This approval strengthens Zydus’ position in the US pharmaceutical market, bringing the company’s total to 419 approvals. Since beginning its filing process in the 2003-04 fiscal year, Zydus has filed 483 Abbreviated New Drug Applications (ANDAs) with the FDA as of December 31, 2024.

The company disclosed this information in a filing with the BSE Limited and National Stock Exchange of India Limited today, noting that the submission of the press release was delayed due to coordination with stakeholders across different global time zones.