Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Methenamine Hippurate Tablets USP, 1 gram (generic version of Hiprex® Tablets). This approval strengthens Zydus’ commitment to providing affordable and high-quality healthcare solutions.
About Methenamine Hippurate Tablets
Methenamine Hippurate tablets are used for the prophylactic or suppressive treatment of frequently recurring urinary tract infections (UTIs) when long-term therapy is required. These tablets will be manufactured at Zydus Lifesciences Ltd (SEZ), Ahmedabad, India.
Market Impact
The U.S. market for Methenamine Hippurate tablets was valued at USD 32.6 million (IQVIA MAT, January 2025). With this approval, Zydus aims to expand its presence in the growing urinary tract infection treatment segment.
Zydus’ Strong Regulatory Track Record
With this latest approval, Zydus now has 419 USFDA approvals and has filed 483 ANDAs since FY 2003-04, reinforcing its strong position in the global pharmaceutical market.
