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Lupin Secures USFDA Approval for Prucalopride Constipation Treatment

It follows a quarter in which US sales climbed to $245 million, positioning Lupin to compete in a $184 million market.

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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.