Aurobindo Pharma has secured a fresh regulatory win in the United States, receiving final approval from FDA to manufacture and market Glycerol Phenylbutyrate Oral Liquid.

 

The drug is a bioequivalent and therapeutically equivalent version of Ravicti, originally developed by Horizon Therapeutics US Holding LLC, and is used to treat patients with urea cycle disorders (UCDs)—a rare but serious condition requiring long-term management.

 

The company said production will be handled at its Unit-III facility, with an immediate market launch planned—signalling a rapid commercial rollout in a segment valued at approximately $50.2 million for the 12 months ending February 2026, according to IQVIA data.

 

This latest clearance adds to Aurobindo’s growing US regulatory footprint, taking its total to 579 ANDA approvals, including 556 final approvals and 23 tentative ones from the USFDA.

 

Glycerol Phenylbutyrate Oral Liquid functions as a nitrogen-binding agent, prescribed for chronic management of patients who cannot rely solely on dietary protein restriction or amino acid supplementation.