Zydus receives final approval from USFDA for Cevimeline Hydrochloride Capsules 30mg

Zydus Lifesciences Limited., ("Zydus") has received final approval from the United States Food and Drug Administration (USFDA) for Cevimeline Hydrochloride Capsules 30 mg, (USRLD: Evoxac® Capsules, 30 mg).

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren's syndrome. Cevimeline is a muscarinic receptor agonist that stimulates salivary secretion. Cevimeline hydrochloride 30 mg capsules will be produced at the Group's manufacturing facility at SEZ-II, Ahmedabad.

Cevimeline Hydrochloride Capsules 30mg had annual sales of USD 26.9 mn. (IQVIA MAT Jan-26).

The group now has 436 approvals and has so far filed 505* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 916.55 as compared to the previous close of Rs. 922.00. The total number of shares traded during the day was 15655 in over 2032 trades.

The stock hit an intraday high of Rs. 926.00 and intraday low of 909.15. The net turnover during the day was Rs. 14367856.00.

(*As on 31-Dec-2025)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA FinalApproval CevimelineHydrochloride Capsules