Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid

Lupin Receives U.S. FDA Approval for Glycerol Phenylbutyrate Oral Liquid

MUMBAI, India and NAPLES, Fla, May 5, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.

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, of Horizon Therapeutics U.S. Holding LLC. It is indicated for chronic management of patients with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

The product sales for Glycerol Phenylbutyrate Oral Liquid (RLD Ravicti®) were USD 337 million for the year ended December 2025. (IQVIA MAT DEC 2025)

About Lupin
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. Trusted by healthcare professionals and consumers globally, the company enjoys 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 dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

*Safe Harbor Statement

Ravicti® is the registered trademark of Horizon Therapeutics U.S. Holding LLC, a subsidiary of Amgen Inc.

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SOURCE Lupin Pharmaceuticals, Inc.