Zydus Lifesciences Restricted introduced at present it has obtained 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 therapy of ceaselessly 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 at present at 2.45 pm.
The tablets will probably 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 US 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 data in a submitting with the BSE Restricted and Nationwide Inventory Change of India Restricted at present, noting that the submission of the press launch was delayed as a consequence of coordination with stakeholders throughout totally different world time zones.
