Aurobindo Pharma Receives USFDA Nod for Glycerol Phenylbutyrate Launch

Aurobindo Pharma Ltd has achieved final approval from the USFDA to produce and distribute a generic glycerol phenylbutyrate oral liquid, intended to manage high blood ammonia levels due to urea cycle disorders. The product, equivalent to Ravicti, meets chronic patient management needs and is set for immediate launch.

Aurobindo Pharma Ltd announced it has secured final approval from the United States Food & Drug Administration to manufacture and market its generic glycerol phenylbutyrate oral liquid.

This medication targets high ammonia levels in the blood caused by urea cycle disorders, aligning with Ravicti by Horizon Therapeutics in terms of both bioequivalence and therapeutic equivalent.

Set to be produced at the company's Unit-III, the approved product captures an estimated USD 50.2 million market for the period ending February 2026, per IQVIA MAT data.

(With inputs from agencies.)