Aurobindo Pharma Gets USFDA Nod for Generic Ravicti to Treat Urea Cycle Disorders
New Delhi: Aurobindo Pharma Limited has received final approval from the United States Food and Drug Administration (USFDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, a bioequivalent and therapeutically equivalent version of Ravicti Oral Liquid of Horizon Therapeutics U.S. Holding LLC.
The company is set to manufacture the product at its Unit-III facility and launch it immediately in the US market, which has an estimated size of $50.2 million for the 12 months ending February 2026.
The approval marks a significant addition to Aurobindo Pharma’s US portfolio, taking its total ANDA approvals to 579, comprising 556 final approvals and 23 tentative approvals from the USFDA.
Glycerol Phenylbutyrate Oral Liquid is indicated for use as a nitrogen-binding agent in the chronic management of patients with urea cycle disorders (UCDs), particularly those who cannot be effectively managed through dietary protein restriction and/or amino acid supplementation alone.
The company confirmed that the product will be manufactured at its Unit-III facility and will be commercialised immediately following approval, strengthening its presence in the US generics segment.
Aurobindo Pharma Limited, headquartered in Hyderabad, is an integrated global pharmaceutical company engaged in the development, manufacturing, and commercialization of generic pharmaceuticals, branded specialty products, and active pharmaceutical ingredients across more than 150 countries.
The company operates over 30 manufacturing and packaging facilities worldwide, which are approved by major regulatory authorities including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.
Its product portfolio spans seven major therapeutic areas including CNS, anti-retroviral, cardiovascular, antibiotics, gastroenterological, anti-diabetics, and anti-allergic segments, supported by a strong research and development framework.
The company also noted that forward-looking statements in the release are subject to risks and uncertainties that could cause actual outcomes to differ materially, and it undertakes no obligation to update such statements publicly.
