Overview
- Lupin received USFDA approval on June 25 for its ANDA of Prucalopride Tablets in 1 mg and 2 mg strengths to treat adult chronic idiopathic constipation.
- The FDA has deemed Prucalopride bioequivalent to Takeda’s Motegrity® Tablets.
- The tablets will be manufactured at Lupin’s Goa facility in India.
- In fiscal Q4, Lupin’s revenue rose 12.2% to ₹5,567.1 crore while EBITDA increased 22.5% to ₹996.85 crore.
- Shares of Lupin Ltd jumped up to 1.5% following the approval announcement, reflecting investor confidence in its US expansion.