Zydus Lifesciences Limited has informed the Exchange regarding a press release dated February 28, 2026, titled "Zydus receives final approvals from USFDA for Ivermectin Tablets USP, 3 mg and Dapsone Tablets USP, 25 mg and 100 mg".
ZYDUSLIFE · price
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Zydus Lifesciences has received final USFDA approvals for Ivermectin Tablets USP, 3 mg (anti-parasitic) and Dapsone Tablets USP, 25 mg and 100 mg (for leprosy and dermatitis herpetiformis). Ivermectin targets a USD 14.8 million annual US market, while Dapsone targets USD 8.4 million, together opening a combined addressable market of around USD 23.2 million. Both products will be made at the group's Ahmedabad SEZ facilities and sold in the US through Viona Pharmaceuticals. With these additions, Zydus has now secured 434 ANDA approvals and filed 505 ANDAs since FY 2003-04.
Positive for shareholders — these approvals strengthen Zydus's US generics pipeline and provide an incremental revenue opportunity from a USD 23+ million addressable market, though the immediate impact on overall earnings will be modest given the relatively small individual product sizes.