Aurobindo Pharma gets USFDA nod for Dextromethorphan Polistirex

Aurobindo Pharma Ltd has received final USFDA approval to manufacture and market 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. The product will be manufactured at APL Healthcare Limited, a wholly-owned subsidiary, and is slated for launch in Q2FY27. The approved product addresses an estimated market size of US$ 138 million for the twelve months ending February 2026. This approval increases Aurobindo Pharma's total USFDA ANDA approvals to 580 (557 final and 23 tentative).