Mumbai, Naples, June 25, 2025: 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.

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).

About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com  or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact –

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

*Safe Harbor Statement
Motegrity® is the registered trademark of Takeda Pharmaceuticals U.S.A. Inc.