Aurobindo Pharma gets USFDA nod for Glycerol Phenylbutyrate Oral Liquid

Aurobindo Pharma Ltd has received final approval from the US FDA to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. This product is bioequivalent and therapeutically equivalent to Ravicti Oral Liquid of Horizon Therapeutics. The drug, indicated for chronic management of urea cycle disorders, will be manufactured by the company's Unit-III and launched immediately. The estimated market size for this product was US$ 50.2 million for the twelve months ending February 2026. This approval increases Aurobindo Pharma's total USFDA ANDA approvals to 579.