Alembic Pharma gets USFDA final approval for Prucalopride Tablets

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, in 1 mg and 2 mg strengths. This approval makes the company's product therapeutically equivalent to Takeda Pharmaceuticals USA Inc.'s Motegrity Tablets. Prucalopride tablets are used to treat chronic idiopathic constipation in adults. The estimated market size for these tablets was US$100 million for the twelve months ending March 2026. This marks Alembic's 225th final ANDA approval from the USFDA, contributing to their cumulative total of 245 approvals.