Lupin Limited has announced that it has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. The approval marks an important addition to the company’s portfolio in the United States market.
The approved formulation is therapeutically equivalent to the reference listed drug Ravicti, developed by Horizon Therapeutics US Holding LLC. The medication is indicated for the long-term management of patients diagnosed with urea cycle disorders, particularly in cases where dietary protein restriction and amino acid supplementation alone are not sufficient to control the condition.
Glycerol Phenylbutyrate Oral Liquid plays a key role in helping patients manage ammonia levels in the blood, a critical factor in treating urea cycle disorders. By offering a bioequivalent alternative, Lupin aims to expand access to this therapy while maintaining established standards of safety, quality, and efficacy.
According to market data, the reference product recorded sales of approximately USD 337 million for the year ending December 2025, indicating significant demand for this treatment in the U.S. healthcare market. The approval positions Lupin to participate in this segment with a cost-effective alternative.
Headquartered in Mumbai, Lupin Limited operates across more than 100 markets worldwide and is recognized for its broad pharmaceutical portfolio. The company’s offerings include branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. It maintains a strong presence in key therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin supports its global operations through an extensive network of 15 manufacturing facilities and seven research centres. Its workforce of over 24,000 professionals drives innovation and ensures compliance with international quality standards.
In addition to its core pharmaceutical business, the company continues to expand its healthcare ecosystem through subsidiaries focused on diagnostics, digital health, and manufacturing solutions. With this latest regulatory approval, Lupin reinforces its commitment to improving patient access to essential treatments and strengthening its footprint in the U.S. pharmaceutical market.
