Lupin Limited has 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, marking another addition to its US generics portfolio.
In a press release dated May 5, 2026, the company said the approved product is bioequivalent to the reference listed drug (RLD), Ravicti Oral Liquid, developed by Horizon Therapeutics U.S. Holding LLC. The medication is indicated for the chronic management of patients with urea cycle disorders (UCDs), a rare condition that requires long-term therapeutic intervention.
The approval provides Lupin access to a niche but meaningful market in the United States. According to IQVIA data, the reference product Ravicti recorded annual sales of approximately $337 million for the 12 months ended December 2025. The development is expected to strengthen Lupin’s presence in the complex generics and specialty segments, particularly in the US market, which remains a key growth driver for Indian pharmaceutical companies.
This approval aligns with Lupin’s strategy of focusing on high-value, limited-competition products in regulated markets. Over the past few years, the company has been increasingly targeting complex generics, specialty products, and differentiated formulations to improve margins and reduce dependency on commoditised generics.
About Lupin:
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence in over 100 markets. The company specialises in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has a strong footprint in India and the United States and operates across multiple therapeutic areas including respiratory, cardiovascular, anti-diabetic, anti-infective, and central nervous system segments. It has a network of manufacturing facilities and research centres globally, supported by a workforce of over 24,000 professionals.