Lupin Limited has informed the Exchange regarding a press release dated Jun 25, 2025, titled "Lupin Receives Approval from U.S. FDA for Prucalopride Tablets".
LUPIN · price
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On the reaction day the stock moved 0.5 pts less than Nifty Midcap 150 and 0.9 pts less than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.
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Lupin has received U.S. FDA approval for its generic version of Prucalopride Tablets (1 mg and 2 mg), which is bioequivalent to Takeda's Motegrity® used to treat chronic idiopathic constipation in adults. The product will be manufactured at Lupin's Goa facility in India. The reference branded drug had estimated annual U.S. sales of USD 184 million (IQVIA MAT April 2025). This approval strengthens Lupin's presence in the U.S. gastrointestinal segment and adds to its growing portfolio of complex generics.
Positive for the stock — this opens a new revenue stream in the lucrative U.S. generics market, targeting a USD 184 million opportunity. The company can now launch the product and capture market share, potentially boosting U.S. business growth in coming quarters.