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

Global pharma major Lupin Limited (Lupin) 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)

Shares of Lupin Limited was last trading in BSE at Rs. 2350.95 as compared to the previous close of Rs. 2303.70. The total number of shares traded during the day was 31456 in over 2972 trades.

The stock hit an intraday high of Rs. 2361.25 and intraday low of 2305.40. The net turnover during the day was Rs. 73816827.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals USFDA Approval GlycerolPhenylbutyrate OralLiquid