Zydus Lifesciences Limited has informed the Exchange regarding a press release dated Jun 02, 2025, titled "Zydus receives tentative approval from the USFDA for Rifaximin Tablets 550mg".
ZYDUSLIFE · price
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Zydus Lifesciences has received a tentative approval from the USFDA for Rifaximin Tablets 550 mg, a generic of Xifaxan® used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. The product will be manufactured at the group's SEZ II facility in Ahmedabad. The US market for Rifaximin tablets is sizeable, with annual sales of USD 2,672.9 million (IQVIA MAT March 2025). This is a tentative approval, meaning Zydus can launch only after patent or exclusivity barriers on the brand expire. With this addition, Zydus now holds 427 USFDA approvals and has filed 492 ANDAs since FY 2003-04.
Tentative approval strengthens Zydus's US generic pipeline but does not allow immediate launch, so near-term revenue impact is limited. Once it converts to final approval, the large addressable market (USD 2.67 billion) could make it a meaningful contributor, mildly positive for long-term growth.