Lupin Ltd
Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator for its generic version of Prucalopride tablets indicated for treatment of chronic idiopathic constipation.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application of Prucalopride tablets of strengths 1 mg and 2 mg, Lupin Ltd said in a regulatory filing.
These are bioequivalent to Motegrity Tablets, 1 mg and 2 mg of Takeda Pharmaceuticals USA. Inc, it added.
"This product will be manufactured at Lupin's Goa facility in India," the company said.
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Citing IQVIA MAT April 2025 data, the company said Prucalopride tablets 1 mg and 2 mg had estimated annual sales of USD 184 million in the US.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application of Prucalopride tablets of strengths 1 mg and 2 mg, Lupin Ltd said in a regulatory filing.
These are bioequivalent to Motegrity Tablets, 1 mg and 2 mg of Takeda Pharmaceuticals USA. Inc, it added.
"This product will be manufactured at Lupin's Goa facility in India," the company said.
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
Citing IQVIA MAT April 2025 data, the company said Prucalopride tablets 1 mg and 2 mg had estimated annual sales of USD 184 million in the US.
