Zydus Lifesciences Limited has informed the Exchange regarding a press release dated March 13, 2026, titled "Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg".
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Zydus Lifesciences has received final approval from the USFDA to market Cevimeline Hydrochloride Capsules 30mg in the United States. The drug is a generic equivalent of Evoxac® Capsules and is used to treat dry mouth in patients with Sjögren's syndrome. The product targets a US market with annual sales of about USD 26.9 million as per IQVIA data for January 2026. Manufacturing will happen at the company's SEZ-II facility in Ahmedabad. With this approval, Zydus now holds 436 total approvals and has filed 505 ANDAs since FY 2003-04, strengthening its US generics portfolio.
This is a positive development as it adds another product to Zydus's US portfolio with a USD 26.9 million addressable market opportunity. The approval reinforces the company's strong track record in US generic filings and should support future US revenue growth, though the stock impact will depend on competitive dynamics and Zydus's market share capture.