Aurobindo Pharma Secures USFDA Approval for Glycerol Phenylbutyrate Oral Liquid
Aurobindo Pharma gains after receving USFDA nod for Glycerol Phenylbutyrate Oral Liquid
Business Standard
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Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (USFDA) to market Glycerol Phenylbutyrate Oral Liquid, a product with an estimated market size of $50.2 million. This approval increases the company's total ANDA approvals to 579, enhancing its portfolio in the pharmaceutical market.
- 01Aurobindo Pharma received USFDA approval for Glycerol Phenylbutyrate Oral Liquid.
- 02The product is bioequivalent to Ravicti, marketed by Horizon Therapeutics.
- 03The estimated market size for the drug is $50.2 million by February 2026.
- 04Aurobindo's total ANDA approvals now stand at 579.
- 05The company reported a 7.6% rise in net profit in Q3 FY26.
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Aurobindo Pharma has announced that it received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid at a concentration of 1.1 grams per ml. This product is bioequivalent and therapeutically equivalent to Ravicti, which is marketed by Horizon Therapeutics U.S. Holding LLC. The drug is indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed through dietary protein restriction and amino acid supplementation alone. The product will be manufactured at Aurobindo's Unit-III facility and will be launched immediately. According to IQVIA MAT data, the estimated market size for Glycerol Phenylbutyrate Oral Liquid is $50.2 million for the 12 months ending February 2026. With this approval, Aurobindo Pharma's total Abbreviated New Drug Application (ANDA) approvals from the USFDA have reached 579, comprising 556 final approvals and 23 tentative approvals. Additionally, the company reported a 7.6% increase in consolidated net profit to โน910.29 crore (approximately $110 million USD) on a 9% rise in net sales to โน8,604.51 crore (approximately $1.04 billion USD) in Q3 FY26 compared to Q3 FY25. Following this announcement, Aurobindo's stock rose 0.09% to โน1,387.30 on the Bombay Stock Exchange (BSE).
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The approval of Glycerol Phenylbutyrate Oral Liquid will enhance Aurobindo Pharma's product offerings, potentially leading to increased revenue and job stability within the company.
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