Alembic Pharma Receives USFDA Approval for Generic Prucalopride Tablets

Alembic Pharmaceuticals Ltd. has bolstered its presence in the U.S. healthcare market after securing final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for generic prucalopride tablets in 1 mg and 2 mg dosages. Therapeutic equivalence to Takeda Pharmaceuticals' Motegrity tablets allows Alembic to offer a cost-effective generic alternative for treating chronic idiopathic constipation (CIC) in adults. With the U.S. market for prucalopride estimated at roughly ₹940 crore ($100 million), this milestone enhances the company’s formulation export portfolio and underscores its strategic commitment to high-value, complex generic drug development. This regulatory win highlights Alembic’s continued emphasis on stringent compliance, research, and high-quality manufacturing to expand its footprint in international, regulated markets. More broadly, the approval exemplifies the strength of India's overall pharmaceutical sector as a major supplier of affordable, top-tier global therapeutics. By continuously expanding its pipeline of FDA-cleared generic medicines, the company strengthens both its individual export capabilities and India’s global reputation as a dependable hub for generic pharmaceuticals. $APLLTD