3 days ago
Zydus Lifesciences gets USFDA nod for Prucalopride tablets, 1 mg and 2 mg
Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) to market Prucalopride Tablets, 1 mg and 2 mg (reference listed drug: Motegrity® ). The tablets are indicated for the treatment of chronic idiopathic constipation (CIC) — a condition in which the cause of constipation is unknown and persistent.
Prucalopride works by stimulating natural peristalsis in the colon, thereby aiding regular bowel movements. With this approval, Zydus adds another feather to its cap in the US generics market. The approved tablets will be manufactured at the company's SEZ facility in Ahmedabad, Gujarat.
According to IQVIA MAT data for June 2025, Prucalopride tablets had annual sales of USD 186.8 million in the US market. This approval strengthens Zydus' position in the gastrointestinal segment and adds to its growing US portfolio.
With this latest nod, the group has now received 422 approvals since it began filing ANDAs (Abbreviated New Drug Applications) in FY 2003-04. In total, Zydus has filed 483 ANDAs so far.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
