Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to manufacture its generic version of Methenamine Hippurate tablets used in treatment of urinary tract infections.
The approval by the US Food and Drug Administration is for manufacturing Methenamine Hippurate tablets of strength 1 gram, Zydus Lifesciences said in a regulatory filing.
The tablets will be produced at Zydus Lifesciences SEZ, Ahmedabad, the company said.
Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary, it added.
Citing IQVIA MAT January 2025 data, the company said Methenamine Hippurate tablets had annual sales of $32.6 million in the US.
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