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

Zydus Lifesciences Limited has received final approval from the USFDA for Prucalopride Tablets, 1 mg and 2 mg. Prucalopride is used for chronic idiopathic constipation, stimulating natural muscle contractions in the colon to promote regular bowel movements. The tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. The group now has 422 approvals and has filed 483 ANDAs since FY 2003-04. Prucalopride tablets had annual sales of USD 186.8 mn in the United States (IQVIA MAT June 2025).