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

June 2, 2025 BSE Limited Code: 532321 1st Floor, P J Towers, Dalal Street, Mumbai-400001 National Stock Exchange of India Limited Code: Zyduslife Exchange Plaza, 5th Floor, Plot No. C/1, G Block, Bandra-Kurla Complex, Bandra (East), Mumbai-400051 Re.: Press Release Dear Sir / Madam, Please find enclosed a copy of press release dated June 2, 2025, titled “Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg.” The contents of the press release give full details. Please bring the aforesaid news to the notice of the members of the exchange and the investors’ at large. Thanking you, Yours faithfully, For, ZYDUS LIFESCIENCES LIMITED DHAVAL N. SONI COMPANY SECRETARY AND COMPLIANCE OFFICER MEMBERSHIP NO. FCS7063 Encl.: As above Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg Ahmedabad, India, June 2, 2025 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. (*As on 31st March, 2025)

The release as fetched from its publisher. zyduslife.com ↗