Lupin Limited 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 Ravicti Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC.

Glycerol Phenylbutyrate Oral Liquid is indicated for the chronic management of patients suffering from urea cycle disorders (UCDs) that cannot be effectively managed through dietary protein restriction or amino acid supplementation alone.

According to IQVIA MAT December 2025 data, Ravicti® Oral Liquid recorded annual sales of approximately USD 337 million in the United States market.