Zydus receives final approval from USFDA for Prucalopride Tablets, 1 mg and 2 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) for Prucalopride Tablets, 1 mg and 2 mg (USRLD: Motegrity ® Tablets, 1 mg and 2 mg).

Prucalopride is prescribed for chronic idiopathic constipation (CIC), a condition where the cause of constipation is unknown. It helps stimulate peristalsis, natural muscle contractions in the colon, to promote more regular bowel movements. Prucalopride tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Prucalopride tablets had annual sales of USD 186.8 mn in the United States (IQVIA MAT June 2025).

The group now has 422 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 935.50 as compared to the previous close of Rs. 945.35. The total number of shares traded during the day was 100291 in over 3610 trades.

The stock hit an intraday high of Rs. 951.40 and intraday low of 931.40. The net turnover during the day was Rs. 94665501.00.

(*As on 31st July 2025)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA FinalApproval PrucaloprideTablets