Lupin gains FDA approval and launches prucalopride tablets
Lupin Limited (BSE: LUPIN) announced it has received U.S. FDA approval for its Abbreviated New Drug Application for Prucalopride Tablets, 1 mg and 2 mg, bioequivalent to Motegrity® Tablets, and has launched the product in the United States. This medication, indicated for treating chronic idiopathic constipation (CIC) in adults, will be manufactured at Lupin's Goa facility in India. With estimated annual sales of USD 184 million in the U.S., the launch strengthens Lupin’s presence in the gastrointestinal therapeutic area. In related news, Lupin also disclosed the allotment of 20,653 equity shares of ₹ 2 each under its ESOP, increasing its issued and paid-up share capital to ₹ 91,34,32,246, comprised of 45,67,16,123 equity shares.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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