Aurobindo Pharma Gets USFDA Nod for Glycerol Phenylbutyrate

Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. The product is bioequivalent and therapeutically equivalent to the reference listed drug Ravicti, marketed by Horizon Therapeutics in the United States.

Product Details and Usage

Glycerol Phenylbutyrate Oral Liquid is used as a nitrogen-binding agent for the chronic management of patients suffering from urea cycle disorders. These are rare genetic conditions where the body is unable to remove ammonia effectively. The drug is prescribed for patients who cannot be managed through dietary protein restriction or amino acid supplementation alone.

Manufacturing and Launch Plans

The product will be manufactured at Aurobindo Pharma’s Unit-III facility. The company has indicated that the product will be launched immediately, allowing it to quickly tap into the market opportunity in the United States.

Market Opportunity and Portfolio Strength

The approved drug addresses an estimated market size of $50.2 million for the twelve months ending February 2026, according to IQVIA data. 

With this approval, Aurobindo Pharma continues to strengthen its presence in the specialty and rare disease segment. The company now has a total of 579 ANDA approvals from the USFDA, including 556 final approvals and 23 tentative approvals.

Aurobindo Pharma Share Price Today

On April 17, 2026, Aurobindo Pharma share price opened at ₹1,388.90, touching the day’s high at ₹1,394.90, as of 10:54 AM on the NSE.

Also Read: Aurobindo Pharma’s Arm Expands MSD Partnership with New Biologics Facility!

Conclusion

The USFDA approval marks a significant milestone for Aurobindo Pharma, enhancing its specialty product portfolio and expanding its footprint in the US market. With immediate launch plans and a targeted niche segment, the company is well-positioned to leverage this opportunity for future growth.

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