Lupin gets USFDA’s nod for Prucalopride Tablets
This product will be manufactured at Lupin’s Goa facility in India
Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Prucalopride Tablets, 1 mg, and 2 mg. Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc. This product will be manufactured at Lupin’s Goa facility in India. Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity) had estimated annual sales of $184 million in the U.S. (IQVIA MAT April 2025).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
