Shares of Aurobindo Pharma Limited edged up on 17 April after the company secured final approval from the US Food and Drug Administration for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. At 11:47 am, the stock was trading up by 0.07% at Rs 1,387.50 on NSE.

In an exchange filing on 17 April, the Hyderabad-based company disclosed the approval to manufacture and market the product, which is bioequivalent and therapeutically equivalent to Ravicti Oral Liquid 1.1 grams per mL, the reference listed drug of Horizon Therapeutics U.S. Holding LLC.

Valued at an estimated $50.2 million for the 12 months ending February 2026, according to IQVIA MAT data, the product will be manufactured at the company’s Unit-III facility. Launch is planned immediately. The drug is indicated for chronic management of urea cycle disorder patients who cannot be managed through dietary protein restriction or amino acid supplementation alone. UCDs are rare metabolic conditions requiring specialist treatment.

With this latest nod, Aurobindo Pharma now holds a cumulative 579 ANDA approvals from the USFDA, comprising 556 final approvals and 23 tentative approvals. Earlier this week, the firm’s subsidiary TheraNym Biologics Pvt. Ltd. expanded its contract manufacturing agreement with Merck Sharp & Dohme Singapore Trading Pte. Ltd. to build a greenfield drug substance facility, Unit 2.

The stock hit a fresh 52-week high of Rs 1,394.90 intraday on 17 April. It has gained 7.92% over the past month and 18.45% over one year on NSE.Unlock profitable opportunities every day!

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