Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride tablets, 1 mg and 2 mg.

The approved product is therapeutically equivalent to Takeda Pharmaceuticals USA Inc.'s Motegrity Tablets and is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

According to IQVIA, Prucalopride Tablets, 1 mg and 2 mg, had an estimated US market size of US$ 100 million for the 12 months ended March 2026.

The approval further strengthens Alembic's US generics portfolio as the company continues to expand its presence in regulated markets.