Lupin Gets USFDA Nod for Generic Ravicti Oral Liquid for Urea Cycle Disorders
New Delhi: Global pharma major Lupin Limited on Tuesday announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.
The approved product is bioequivalent to the reference listed drug (RLD), Ravicti® Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC. It is indicated for the chronic management of patients with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
According to IQVIA MAT data for December 2025, the reference product Ravicti® Oral Liquid recorded sales of USD 337 million.
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence in over 100 markets. The company specialises in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
It has a strong presence in India and the United States across key therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin operates 15 manufacturing facilities and 7 research centres globally and employs over 24,000 professionals. Its subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
