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.
