Business EconomyPosted at: Jun 25 2025 5:53PM


Lupin gets approval from U.S FDA for Prucalopride Tablets

Hyderabad, June 25 (UNI) Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Prucalopride Tablets, 1 mg, and 2 mg. Prucalopride Tablets
are bioequivalent to Motegrity® Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc.
This product will be manufactured at Lupin’s Goa facility in India, the Mumbai based Pharma company said in a release.
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in
adults.
Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity®) had estimated annual sales of USD 184 million in the U.S. (IQVIA MAT April 2025).
Specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, the company has 15
state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated
workforce of over 23,000 professionals.
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Tags: #Lupin gets approval from U.S FDA for Prucalopride Tablets
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