Aurobindo Pharma Ltd on Friday (April 17) said it has received final approval from the US Food and Drug Administration (FDA) to manufacture and market dextromethorphan polistirex extended-release oral suspension, 30 mg/5 mL (OTC).
Aurobindo Pharma said the product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym extended-release oral suspension, 30 mg/5 mL, of RB Health (US) LLC. The company said the product will be manufactured at unit-IV of APL Healthcare Limited, a wholly-owned subsidiary, and is scheduled for launch in Q2FY27.
Aurobindo Pharma said the product has an estimated market size of $138 million for the 12 months ending February 2026, according to Nielsen data. It said with this approval, it now has a total of 580 ANDA approvals from the FDA, including 557 final approvals and 23 tentative approvals.
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The approved formulation is indicated for temporary relief of cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants, and to suppress the impulse to cough to aid sleep.
Earlier on Friday, Aurobindo Pharma said it had received final approval from the FDA for glycerol phenylbutyrate oral liquid, 1.1 grams per ml.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug, Ravicti oral liquid, of Horizon Therapeutics US Holding LLC. The company said the product will be manufactured at its unit-III facility and will be launched immediately.
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The drug is indicated for the chronic management of patients with urea cycle disorders (UCDs) who cannot be managed through dietary protein restriction or amino acid supplementation alone.
Shares of Aurobindo Pharma Ltd ended at ₹1,384.45, down by ₹1.65, or 0.12%, on the BSE today, April 17.
(Edited by : Shoma Bhattacharjee)
First Published: Apr 17, 2026 8:03 PM IST
