Zydus Life gets US FDA nod for UTI treatment drug Methenamine

Zydus Lifesciences said that it has received final approval from the United States Food and Drug Administration (US FDA) to manufacture Methenamine Hippurate Tablets.

The approved ANDA is a generic version of the US reference listed drug (USRLD) Hiprex Tablets.

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 $32.6 million 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.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.

The scrip fell 1.73% to currently trade at Rs 884.35 on the BSE.

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