USFDA okays Lupin Prucalopride Tablets for chronic idiopathic constipation
Mumbai: Global pharma major Lupin Limited has received a green light 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 for the treatment of chronic idiopathic constipation (CIC) in adults.
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, 1 mg, and 2 mg (RLD Motegrity) had estimated annual sales of USD 184 million in the U.S. (IQVIA MAT April 2025).
This is the latest in a series of strategic developments for the company. Earlier this month, Lupin Limited signed a supply and license agreement with Sino Universal Pharmaceuticals (SUP), for the commercialisation of Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule, in the Chinese market, for the treatment of chronic obstructive pulmonary disease (COPD).
Read also: Lupin partners with SUP to bring Tiotropium DPI to COPD patients in China
In addition, Lupin recently received tentative approval from the U.S. FDA for its ANDA for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg for the treatment of partial-onset seizures in patients 6 years of age and older.
Read also: Lupin bags tentative nod from USFDA for partial-onset seizures drug Oxcarbazepine ER
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. The company has 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 workforce of over 23,000 professionals. Lupin has Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions as its subsidaries.
Read also: Lupin's TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel
