Zydus Lifesciences has obtained final approval from the US Food and Drug Administration (FDA) to manufacture and sell Methenamine Hippurate tablets, a generic drug for urinary tract infection (UTI) treatment. The approval adds value to Zydus' product portfolio in the US pharmaceutical sector and is a milestone in its growth strategy.

Key Highlights
FDA Approval and Market Impact

• Methenamine Hippurate tablets are prescribed for prophylactic or suppressive long-term treatment of recurrent urinary tract infection.

• The drug will be produced at Zydus' plant in Ahmedabad and sold in the US.

• According to IQVIA data, the drug had net sales of $32.6 million in the US during the 12 months ended January 2025.

Zydus' Expanding Regulatory Pipeline

• With this newest approval, Zydus has received 419 ANDA (Abbreviated New Drug Application) approvals.

• The firm has submitted 483 ANDAs as of when it started making submissions in FY2003-04.

• This clearance further consolidates Zydus' leadership in the US generics market, which continues to be one of the company's prime revenue earners.

The FDA approval of Methenamine Hippurate tablets is a testament to Zydus Lifesciences' focus on growing its US generics business. With a solid history of regulatory clearances and market access, the company continues to utilize its manufacturing strengths to deliver affordable therapies for chronic and recurrent infections.