Pharma company Lupin on Wednesday announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Prucalopride Tablets, 1 mg, and 2 mg. The drug is used in the treatment of Chronic Idiopathic Constipation in adults (CIC).
The product, it added, will be manufactured at the company’s Goa facility. “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,” Lupin said in a regulatory filing.
According to the IQVIA data dated April 2025, Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity®) had estimated annual sales of $184 million in the US.
Shares of Lupin were up 0.21 per cent at 2:30 pm today at a trading price of Rs 1,934.75.
How did Q4 do for Lupin?
Earlier in May, Lupin had released its fiscal fourth quarter earnings report with profit at Rs 794.86 crore, up 121.1 per cent from Rs 359.43 crore in the previous year. Revenue for the quarter increased by 12.2 per cent from the same quarter last year to Rs 5,567.1 crore. Lupin’s EBITDA increased by 22.5 per cent from last year to Rs 996.85 crore.
The company’s margin expanded to 21.9 per cent in the fourth quarter from 20.1 per cent in the previous year.