Lupin receives USFDA approval for generic Prucalopride tablets

Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Prucalopride tablets.

The tablets are a generic equivalent of Motegrity? Tablets, developed by Takeda Pharmaceuticals U.S.A., Inc., and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Lupin stated that the approved product is bioequivalent to Motegrity? and will be manufactured at the company?s facility in Goa, India.

According to IQVIA MAT data for April 2025, Prucalopride Tablets (Reference Listed Drug: Motegrity?) had estimated annual sales of approximately $184 million in the United States.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company?s consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24.

The scrip rose 0.07% to Rs 1,932.10 on the BSE.

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