Aurobindo Pharma Receives USFDA Approval for Nitrogen-Binding Agent Glycerol Phenylbutyrate
Aurobindo Pharma Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. The approved product is bioequivalent and therapeutically equivalent to Ravicti Oral Liquid 1.1 grams per mL, manufactured by Horizon Therapeutics U.S. Holding LLC.The new product will be manufactured by Unit-III of the company and is scheduled for immediate launch. Glycerol Phenylbutyrate Oral Liquid is indicated for the chronic management of patients with urea cycle disorders (UCDs) who require a nitrogen-binding agent and cannot be managed solely by dietary protein restriction or amino acid supplementation.
The successful approval highlights the drug's market potential, which is estimated by IQVIA MAT to be US$ 50.2 million for the twelve months ending February 2026. With this development, Aurobindo Pharma now reports a total of 579 ANDA approvals from the USFDA, comprising 556 final approvals and 23 tentative approvals.
Global Pharmaceutical Footprint
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The firm specializes in developing, manufacturing, and commercializing a comprehensive portfolio that includes generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients worldwide across over 150 countries.The company operates more than 30 manufacturing and packaging facilities. These facilities have secured approvals from major regulatory bodies, including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.
Aurobindo Pharma's robust product range spans seven major therapeutic areas: CNS, Anti-Retroviral, Cardiovascular Systems (CVS), Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic, all supported by a strong research and development setup.
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