Zydus Lifesciences Restricted introduced immediately it has obtained remaining approval from the US Meals and Drug Administration (USFDA) to fabricate Methenamine Hippurate Tablets USP, 1 gram. The treatment, which is the generic equal of Hiprex Tablets, is used for the prophylactic or suppressive remedy of regularly recurring urinary tract infections.
The shares of Zydus Lifesciences Restricted had been buying and selling at ₹883.50 down by ₹16.35 or 1.82 per cent on the NSE immediately at 2.45 pm.
The tablets shall be produced at Zydus Lifesciences’ facility in Ahmedabad, India. In line with IQVIA knowledge, the accepted treatment generated annual gross sales of $32.6 million in the USA as of January 2025.
This approval strengthens Zydus’ place within the US pharmaceutical market, bringing the corporate’s complete to 419 approvals. Since starting its submitting course of within the 2003-04 fiscal yr, Zydus has filed 483 Abbreviated New Drug Functions (ANDAs) with the FDA as of December 31, 2024.
The corporate disclosed this data in a submitting with the BSE Restricted and Nationwide Inventory Change of India Restricted immediately, noting that the submission of the press launch was delayed on account of coordination with stakeholders throughout completely different international time zones.
