Global pharma major Lupin has announced that the company has received approval from the United States Food and Drug Administration (US FDA) 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 USA Inc. This product will be manufactured at Lupin's Goa facility in India, the company said in a statement.

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 USD 184 million in the US (IQVIA MAT April 2025).

Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company enjoys a strong position in India and the US across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. It has 15 state-of-the-art manufacturing sites and 7 research centres globally.