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(11 Aug 2025, 08:23)

Zydus Lifesciences gets USDFA approval for Prucalopride tablets

Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) for Prucalopride tablets, 1 mg and 2 mg.


The said drug is equivalent to listed drug 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. The said tablets will be produced at the company’s (SEZ), Ahmedabad.

Prucalopride tablets had annual sales of $186.8 million in the United States (IQVIA MAT June 2025).

As on 31st July 2025, the group has 422 approvals and has so far filed 483 ANDA since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company’s consolidated net profit shed 1% to Rs 1,170.90 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24.

The counter fell 1.04% to end at Rs 935.50 on Friday, 8 August 2025.

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