Aurobindo Pharma announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per ml.
The approved product is bioequivalent and therapeutically equivalent to the reference-listed drug, Ravicti, marketed by Horizon Therapeutics U.S. Holding LLC.
The company said the product will be manufactured at its Unit-III facility and will be launched immediately.
According to IQVIA MAT data, the approved drug has an estimated market size of $50.2 million for the 12 months ending February 2026. With this approval, Aurobindo Pharmas total ANDA approvals from the USFDA stand at 579, including 556 final approvals and 23 tentative approvals.
Glycerol phenylbutyrate oral liquid is indicated as a nitrogen-binding agent for the chronic management of patients with urea cycle disorders (UCDs) who cannot be adequately managed through dietary protein restriction and amino acid supplementation alone.
Aurobindo Pharma is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services. The company reported a 7.6% rise in consolidated net profit to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25.
