Lupin receives approval from U.S. FDA for Prucalopride Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. 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 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 USD 184 million in the U.S. (IQVIA MAT April 2025).

Shares of Lupin Limited was last trading in BSE at Rs. 1930.70 as compared to the previous close of Rs. 1928.10. The total number of shares traded during the day was 13572 in over 1332 trades.

The stock hit an intraday high of Rs. 1963.80 and intraday low of 1927.65. The net turnover during the day was Rs. 26406405.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals Approval USFDA ANDA PrucaroprideTablets