Zydus Lifesciences bags USFDA approval for urinary tract infections drug
Ahmedabad: Zydus Lifesciences Limited 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.
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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