Ahmedabad, India, 12 March, 2025
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has
received final approval from the United States Food and Drug Administration (USFDA) to manufacture
Methenamine Hippurate Tablets USP, 1 gram (USRLD: Hiprex ® Tablets, 1 gram).
Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently
recurring urinary tract infections when long-term therapy is considered necessary. Methenamine
Hippurate tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad.
Methenamine Hippurate tablets had annual sales of USD 32.6 mn in the United States (IQVIA MAT
January 2025).
The group now has 419 approvals and has so far filed 483* ANDAs since the commencement of the
filing process in FY 2003-04.
(*As on 31 st December, 2024.)
