Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg (USRLD: Xifaxan® Tablets, 550 mg).

Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets will be produced at the Group's manufacturing site at SEZ II, Ahmedabad.

Rifaximin tablets had annual sales of USD $2672.9 mn in the United States (IQVIA MAT March 2025).

The group now has 427 approvals and has so far filed 492* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 929.85 as compared to the previous close of Rs. 924.50. The total number of shares traded during the day was 13823 in over 1023 trades.

The stock hit an intraday high of Rs. 934.40 and intraday low of 918.00. The net turnover during the day was Rs. 12793877.00.

(*As on 31st March, 2025)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA TentativeApproval RifaximinTablets