The USFDA has approved Lupin’s Prucalopride Tablets, 1 mg, and 2 mg. These tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc.
According to the IQVIA data dated April 2025, the tablets had an estimated annual sales of $184 million in the US market.
This product will be manufactured at Lupin’s Goa facility in India, the drugmaker said in an exchange filing.
Earlier in the month, the company had received tentative approval from the American regulator for Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths. These drugs are slated to be manufactured at the company’s Nagpur facility.
For the March quarter, Lupin’s revenue increased by 12.2% from last year to ₹5,567.1 crore, while its Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) rose by 22.5% from last year to ₹996.85 crore.
Lupin’s key US sales rose to $245 million, higher than the same quarter last year’s figure of $209 million.
The company shares, after opening higher than the previous day’s closing, slumped as the day’s trade progressed, giving up all of those gains.
Shares of Lupin are currently trading little changed at ₹1,932.1. The stock is down 3% over the last month.
Also Read: Lupin shares gain ahead of US drug launch that can fetch $200 million in FY26
