Zydus Lifesciences Limited — Updates, 12-03-2025: Press Release

Zydus Lifesciences Limited has received final approval from the USFDA for Methenamine Hippurate Tablets USP, 1 gram, which are indicated for the prophylactic treatment of recurrent urinary tract infections. This product will be manufactured at Zydus’s facility in Ahmedabad, expanding its portfolio in a significant market segment. The tablets had annual sales of approximately USD 32.6 million in the U.S. as of January 2025, showcasing robust demand. With this approval, Zydus now holds a total of 419 regulatory approvals, having filed 483 abbreviated new drug applications (ANDAs) since FY 2003-04. This development is a positive signal for Zydus, strengthening its competitive position in the pharmaceutical market while contributing to future revenue growth.