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Aurobindo gets nod for Dextromethorphan Polistirex Extended-Release Oral Suspension

18 Apr 2026 Evaluate

Aurobindo Pharma has received United States Food and Drug Administration (USFDA) approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC), which 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 product will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of the company, and will be launched in Q2FY27.

The approved product has an estimated market size of $138 million for the twelve months ending February 2026. Aurobindo Pharma now has a total of 580 ANDA approvals (557 final approvals and 23 tentative approvals) from USFDA. Dextromethorphan Polistirex Extended-Release Oral Suspension (OTC) temporarily relieves (1) cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants (2) the impulse to cough to help one get to sleep.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

Aurobindo Pharma Share Price

1385.65 -0.45 (-0.03%)
17-Apr-2026 16:59 View Price Chart
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