Zydus Lifesciences Restricted introduced immediately it has acquired closing 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 steadily recurring urinary tract infections.
The shares of Zydus Lifesciences Restricted have 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 might be produced at Zydus Lifesciences’ facility in Ahmedabad, India. Based on IQVIA knowledge, the permitted 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 whole to 419 approvals. Since starting its submitting course of within the 2003-04 fiscal yr, Zydus has filed 483 Abbreviated New Drug Purposes (ANDAs) with the FDA as of December 31, 2024.
The corporate disclosed this info 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 totally different world time zones.