Zydus Lifesciences Limited has announced that it has received final approval from the US Food and Drug Administration (USFDA) for the production of Methenamine Hippurate Tablets USP, 1 gram. This medication is the generic equivalent of Hiprex Tablets and 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 at 2.45 pm today.
The tablets will be manufactured at Zydus Lifesciences’ facility in Ahmedabad, India. According to IQVIA data, the approved medication had 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, with a total of 419 approvals. Since initiating the filing process in the 2003-04 fiscal year, Zydus has submitted 483 Abbreviated New Drug Applications (ANDAs) to the FDA as of December 31, 2024.
This information was disclosed in a filing with the BSE Limited and National Stock Exchange of India Limited today, with the company noting that the press release was delayed due to coordination with stakeholders across different global time zones.
