Alembic Pharma Secures USFDA Final Approval for Generic Prucalopride Tablets
New Delhi: 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 generic product is therapeutically equivalent to Motegrity (Prucalopride) Tablets, 1 mg and 2 mg, marketed by Takeda Pharmaceuticals USA Inc.
Prucalopride is a selective serotonin-4 (5-HT4) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. The company advised healthcare professionals to refer to the prescribing information for the complete indication and usage details.
According to IQVIA data for the 12-month period ending March 2026, the reference product has an estimated U.S. market size of US$100 million.
With this approval, Alembic Pharmaceuticals has received a cumulative 245 ANDA approvals from the USFDA, comprising 225 final approvals and 20 tentative approvals.
Headquartered in India, Alembic Pharmaceuticals is a vertically integrated pharmaceutical company engaged in the research, development, manufacturing and marketing of generic medicines globally. The company operates manufacturing and research facilities approved by several international regulatory authorities, including the USFDA, and is also a leading player in India's branded generics market.
