Lupin Limited Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid
Mumbai, India, Naples, Fla, May 5, 2026: Global pharmaceutical major Lupin Limited today announced that it has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Applications (ANDAs) concerning Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.This newly approved product, Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, is bioequivalent to the reference listed drug (RLD), Ravicti® Oral Liquid, 1.1 grams per mL, manufactured by Horizon Therapeutics U.S. Holding LLC. The drug is indicated for the chronic management of patients dealing with urea cycle disorders (UCDs) that cannot be managed solely through dietary protein restriction and/or amino acid supplementation.
The market potential for the drug is significant. Lupin noted that the product sales for the RLD, Ravicti®, reached USD 337 million for the year ended December 2025, according to IQVIA data.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company specializes in pharmaceutical products, offering both branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has established a strong presence in the U.S. and India across multiple therapeutic areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. The company operates through 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals. Lupin also operates subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, which are dedicated to improving patient health outcomes.
LUPIN Stock Price Movement
As of 9:38 AM, shares of Lupin Limited are shedding 0.42% in live trading, falling to ₹2339. Despite the stock recently achieving its 52-week high, the equity continues active trading volume, with 133,724 shares transacted so far.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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