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Corporate News

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(13 Mar 2026, 10:23)

Zydus Life receives USFDA nod for Cevimeline 30 mg capsules

Zydus Lifesciences said it has received final approval from the United States Food and Drug Administration (USFDA) for Cevimeline Hydrochloride Capsules 30 mg.


The drug is the generic version of Evoxac Capsules, 30 mg. It is indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome and works as a muscarinic receptor agonist that stimulates salivary secretion. The capsules will be manufactured at the group’s formulation facility at SEZ-II, Ahmedabad.

According to IQVIA MAT January 2026 data, the product recorded annual sales of $26.9 million in the United States. With this approval, the group now has 436 USFDA approvals and has filed 505 ANDAs since it began filing in FY2003-04.

Zydus Life Sciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing, and distribution of pharmaceutical products.

The company’s consolidated net profit rose 7.7% to Rs 1,102.64 crore on a 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25.

Shares of Zydus Lifesciences fell 0.98% to Rs 907.50 on the BSE.

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