Constipation Conquered: Lupin Bags USFDA Nod for $184 Million Prucalopride Tablets

  • Lupin Limited, a leading Mumbai-based pharma giant, has secured final approval from the US Food and Drug Administration (USFDA) for its Prucalopride Tablets, 1 mg and 2 mg, designed to treat chronic idiopathic constipation (CIC) in adults.

  • These tablets are bioequivalent to Motegrity® by Takeda Pharmaceuticals, targeting a US market with estimated annual sales of $184 million.

  • The approved Prucalopride Tablets will be manufactured at Lupin’s world-class facility in Goa, India, further cementing the company’s manufacturing prowess.

  • This milestone is set to boost Lupin’s already robust US product portfolio, strengthening its position in the fiercely competitive American pharmaceutical market.

  • The approval comes on the heels of Lupin’s strong Q4 performance, with revenue rising 12.2% year-on-year to ₹5,567.1 crore and EBITDA climbing 22.5% to ₹996.85 crore.

  • Lupin’s US business continues to be a key growth driver, and the latest FDA green light is expected to provide a significant revenue surge in the coming fiscal year.

  • The company’s strategic focus on complex generics and expansion in regulated markets highlights its commitment to innovation and global leadership.

  • With this latest win, Lupin is not just treating constipation—it’s pushing the boundaries of pharma success and market expansion.

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