Lupin Secures USFDA Nod for Prucalopride Tablets
Lupin Ltd has obtained approval from the USFDA for its generic Prucalopride tablets used to treat chronic idiopathic constipation. The tablets, available in 1 mg and 2 mg strengths, are bioequivalent to Motegrity Tablets by Takeda Pharmaceuticals. Manufacturing will occur at Lupin's Goa facility in India.
- Country:
- India
Pharmaceutical giant Lupin Ltd announced a significant milestone on Wednesday, receiving approval from the US Food and Drug Administration (USFDA) for its generic version of Prucalopride tablets, which treat chronic idiopathic constipation.
The approval allows Lupin to market its Prucalopride tablets in 1 mg and 2 mg dosages, equivalent to Takeda Pharmaceuticals' Motegrity Tablets. Production is set to take place at Lupin's facility in Goa, India.
According to IQVIA MAT April 2025 data, the US market for Prucalopride tablets is estimated to be worth USD 184 million annually, highlighting the product's significant commercial potential.
(With inputs from agencies.)
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- Lupin
- USFDA
- Prucalopride
- tablets
- constipation
- generic
- approval
- Motegrity
- Takeda
- Goa
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