Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. This product is bioequivalent and therapeutically equivalent to the reference listed drug, Ravicti Oral Liquid 1.1 grams per mL, by Horizon Therapeutics U.S. Holding LLC.
The product will be manufactured at Aurobindo’s Unit-III and is set for immediate launch. The approved product has an estimated market size of US$ 50.2 million for the twelve months ending February 2026, according to IQVIA MAT. With this approval, Aurobindo Pharma now holds a total of 579 ANDA approvals from the USFDA, comprising 556 final approvals and 23 tentative approvals.
Glycerol Phenylbutyrate Oral Liquid is indicated for use as a nitrogen-binding agent for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Aurobindo Pharma is a global pharmaceutical company headquartered in Hyderabad, India, with a presence in over 150 countries. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients. Aurobindo’s extensive product portfolio covers major therapeutic areas, including CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).