USFDA approves Zydus Lifesciences chronic idiopathic constipation drug Prucalopride
Ahmedabad: Zydus Lifesciences Limited 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.
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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.
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Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.
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