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Alembic Pharma gets USFDA’s final approval for Prucalopride Tablets
Jul-28-2026

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Prucalopride Tablets, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc. Prucalopride tablets are serotonin-4 receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 

Prucalopride Tablets, 1 mg and 2 mg, have an estimated market size of $100 million for twelve months ending March 2026 according to IQVIA. Alembic has a cumulative total of 245 ANDA approvals (225 final approvals and 20 tentative approvals) from USFDA.

Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.


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