Zydus Lifesciences shares are likely to remain in focus after the company received final approval from the United States Food and Drug Administration (USFDA) for its Cevimeline Hydrochloride Capsules 30 mg , the generic version of Evoxac capsules.
The approval allows Zydus to manufacture and market the drug in the United States. The capsules are used for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren's syndrome, an autoimmune disorder that affects moisture-producing glands in the body.
Cevimeline acts as a muscarinic receptor agonist, helping stimulate salivary secretion and thereby relieving persistent dry mouth symptoms. The company said the product will be manufactured at its SEZ-II manufacturing facility in Ahmedabad, India.
According to IQVIA data (MAT January 2026), the reference drug recorded annual sales of about USD 26.9 million in the United States, indicating a modest but stable market opportunity for the generic version.
With this latest approval, Zydus Lifesciences has received 436 USFDA approvals and has filed 505 ANDAs since it began the filing process in FY2003-04, further strengthening its presence in the US generics market.