Zydus gets USFDA approval for Methenamine Hippurate 1g tablets

The United States Food and Drug Administration (USFDA) has granted final approval for the manufacturing and marketing of Methenamine Hippurate Tablets USP 1 gram in the U.S.

This approval widens Zydus Lifesciences in the U.S. market, signifying an added leap in its ongoing promise to deliver low-priced and pervasively accessible healthcare solutions. The tablets will be manufactured at Zydus in Ahmedabad, which operates in compliance with the highest quality and regulatory standards.

According to IQVIA MAT data in January 2025, Methenamine Hippurate tablets have generated annual sales of USD 32.6 million in the United States, which shows clearly the market demand for this medicine. This approval makes another landmark for the company, increasing the total number of approvals to 419.

Since the commencement of its filing of ANDAs in FY 2003-04, the company had filed altogether 483 applications, showing the continued effort taken to introduce new medicines in the pipeline.

Methenamine Hippurate tablets are indicated for the prophylactic or suppressive treatment of recurrent urinary tract infections when long-term therapy is needed. The drug acts by converting into formaldehyde in acidic urine. This is an antibacterial agent that prevents the growth of bacteria and reduces the number of UTIs developing.

Thus, this class of treatment is particularly helpful for patients suffering from chronic urinary tract infections and needing long-term management to keep them at bay. With this latest approval, Zydus continues to fortify its standing in the U.S. while delivering high-quality, cost-effective medications to those in need.