Announced Tue, 28 Jul, 2026 · 13:23 IST
Alembic Pharma gets USFDA nod for Prucalopride Tablets 1mg and 2mg
Regulatory Product ApprovalExport Order Hard CurrencyBusiness Updates View source PDFExplain this filing
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AI summary
Alembic Pharmaceuticals received USFDA final approval for its ANDA for Prucalopride Tablets 1 mg and 2 mg, a generic of Takeda's Motegrity used to treat chronic idiopathic constipation in adults. The US addressable market is estimated at around US$100 million for the twelve months ending March 2026 per IQVIA. Alembic now holds 245 cumulative ANDA approvals from USFDA, including 225 final approvals.
Likely market impact
Positive for export revenue. Opens access to a US$100 million US market opportunity, supporting Alembic's US generics growth and margins.