Aurobindo Pharma Secures USFDA Approval for Glycerol Phenylbutyrate Oral Liquid
Aurobindo Pharma receives USFDA approval for Glycerol Phenylbutyrate Oral Liquid
Business Standard
Image: Business Standard
Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) for Glycerol Phenylbutyrate Oral Liquid, a treatment for urea cycle disorders. The product, bioequivalent to Horizon Therapeutics' Ravicti, targets a market estimated at $50.2 million by February 2026.
- 01Aurobindo Pharma's Glycerol Phenylbutyrate Oral Liquid is approved for chronic management of urea cycle disorders.
- 02The product is bioequivalent to Horizon Therapeutics' Ravicti Oral Liquid.
- 03The estimated market size for this product is $50.2 million by February 2026.
- 04This approval adds to Aurobindo's total of 579 ANDA approvals from the USFDA.
- 05The product will be manufactured at Aurobindo's Unit-III and launched immediately.
Advertisement
In-Article Ad
Aurobindo Pharma has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Glycerol Phenylbutyrate Oral Liquid, which contains 1.1 grams per mL. This product is bioequivalent and therapeutically equivalent to the reference listed drug, Ravicti Oral Liquid, developed by Horizon Therapeutics U.S. Holding LLC. The approved Glycerol Phenylbutyrate is indicated for patients with urea cycle disorders (UCDs) who cannot be managed solely through dietary protein restriction or amino acid supplementation. The product is expected to enter a market valued at approximately $50.2 million for the twelve months ending February 2026, according to IQVIA MAT. With this approval, Aurobindo Pharma now holds a total of 579 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which includes 556 final approvals and 23 tentative approvals. The product will be manufactured at the company's Unit-III and is set for immediate launch.
Advertisement
In-Article Ad
The approval of Glycerol Phenylbutyrate Oral Liquid will provide an essential treatment option for patients with urea cycle disorders, enhancing their management and potentially improving their quality of life.
Advertisement
In-Article Ad
Reader Poll
Do you believe new drug approvals significantly improve treatment options for patients?
Connecting to poll...
More about Aurobindo Pharma

Aurobindo Pharma Secures USFDA Approval for Glycerol Phenylbutyrate Oral Liquid
Business Standard โข Apr 17, 2026
Aurobindo Pharma's โน800 Crore Share Buyback: Last Day to Purchase Shares
The Economic Times โข Apr 16, 2026
Upcoming Share Buybacks: Wipro, Aurobindo Pharma, and More
The Economic Times โข Apr 15, 2026
Read the original article
Visit the source for the complete story.




