Aurobindo Pharma Shares Gain Attention Following US FDA Approval for Cough Syrup

Aurobindo Pharma Receives FDA Approval for Two Products

Aurobindo Pharma is set to remain in the spotlight on April 20 as the company has received approval from the U.S. Food and Drug Administration (FDA) for two new products. The first product to receive approval is Dextromethorphan Polistirex extended-release oral suspension (30 mg/5 mL, OTC). This product is bioequivalent and therapeutically equivalent to the reference listed drug Delsym Extended Release Oral Suspension, which is marketed by RB Health (US) LLC.

The Dextromethorphan Polistirex extended-release oral suspension is used for the temporary relief of cough caused by minor throat and bronchial irritation, with the common cold or inhaled irritants, and to help individuals get to sleep. The product will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of Aurobindo Pharma, with a planned launch in Q2 FY27.

In a separate development, the company has received final approval from the FDA to manufacture and market Glycerol Phenylbutyrate Oral Liquid (1.1 g/mL). This product is also bioequivalent and therapeutically equivalent to the reference listed drug Ravicti Oral Liquid, which is marketed by Horizon Therapeutics U.S. Holding LLC. The Glycerol Phenylbutyrate Oral Liquid will be manufactured at Unit-III of the company and Aurobindo Pharma plans an immediate launch in the market.

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