Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 17, 2026, titled "Aurobindo Pharma receives USFDA approval for Glycerol Phenylbutyrate Oral Liquid,1.1 grams per mL".

Regulatory Product ApprovalExport Order Hard CurrencyBusiness Updates View source PDF

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AI summary

Aurobindo Pharma has received final USFDA approval to manufacture and market Glycerol Phenylbutyrate Oral Liquid, a generic version of Horizon Therapeutics' Ravicti Oral Liquid. The product will be produced at the company's Unit-III facility and launched immediately. The approved drug is used as a nitrogen-binding agent for managing urea cycle disorders in patients who cannot be controlled through dietary protein restriction alone. The US market for this product is estimated at US$ 50.2 million for the twelve months ending February 2026. With this approval, Aurobindo Pharma now holds a total of 579 ANDA approvals from USFDA.

Likely market impact

This approval adds a specialty orphan drug to Aurobindo's US portfolio, expanding its therapeutic offerings and contributing to revenue from the large US generic pharmaceutical market in hard currency.