Aurobindo Pharma received final USFDA approval to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.
The approved product addresses urea cycle disorders with an estimated market size of US$50.2 million for twelve months ending February 2026.
The product will be manufactured at Unit-III and launched immediately, bringing total ANDA approvals to 579 (556 final, 23 tentative).