Aurobindo Pharma has received final approval from the USFDA to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. This product, which serves as a nitrogen-binding agent for the management of urea cycle disorders (UCDs), is bioequivalent to the reference listed drug, Ravicti. The drug will be produced at the company’s Unit-III facility and is scheduled for immediate launch, targeting a market size of US$ 50.2 million.
Strategic Market Expansion
Aurobindo Pharma continues to expand its specialty pharmaceutical portfolio with the latest USFDA approval for Glycerol Phenylbutyrate Oral Liquid. This medication is indicated for patients suffering from urea cycle disorders (UCDs) who require nitrogen-binding therapy when dietary protein restriction and amino acid supplementation are insufficient. The approved liquid is therapeutically equivalent to the reference product, Ravicti, originally marketed by Horizon Therapeutics U.S. Holding LLC.
Commercial Details and Portfolio Impact
The product, set to be manufactured at the company’s Unit-III facility, is slated for immediate market launch. According to IQVIA MAT data for the twelve months ending February 2026, the product captures an estimated market size of US$ 50.2 million. With this latest authorization, Aurobindo Pharma has reached a milestone of 579 ANDA approvals, comprising 556 final approvals and 23 tentative approvals, reinforcing the company’s commitment to delivering accessible generic alternatives globally.
Source: BSE
