New Delhi: Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of prucalopride tablets indicated for the treatment of chronic idiopathic constipation in adults.The final approval granted by the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) prucalopride tablets of strengths 1 mg and 2 mg, Alembic said in a statement.Also Read: US tariff proposal wake-up call for Indian pharma to diversify, innovate: ExpertsThe approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Motegrity tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA Inc, it added.Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.Also Read: Novo Nordisk pursues preliminary injunction to block Eli Lilly weight-loss drug adsCiting IQVIA data, the company said prucalopride tablets, 1 mg and 2 mg, had an estimated market size of USD 100 million for 12 months ended March 2026.
Alembic Pharma gets USFDA approval for generic chronic constipation treatment tablets
Alembic Pharmaceuticals announced USFDA approval for its generic prucalopride tablets. The company received final approval for strengths of one and two milligrams. These tablets are indicated for treating chronic idiopathic constipation in adults. The approved drug is therapeutically equivalent to Takeda's Motegrity tablets. This market segment has an estimated size of one hundred million dollars.







