Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 17, 2026, titled "Aurobindo Pharma receives USFDA approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC)".
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Aurobindo Pharma has received final USFDA approval to manufacture and sell Dextromethorphan Polistirex Extended-Release Oral Suspension (30 mg/5 mL), an over-the-counter cough suppressant that is bioequivalent to RB Health's Delsym brand. The product will be made at Unit-IV of its wholly owned subsidiary APL Healthcare Limited and is planned for launch in Q2FY27. The target market in the US is estimated at US$ 138 million for the 12 months ending February 2026, according to Nielsen. With this approval, Aurobindo's total ANDA count from USFDA rises to 580 (557 final and 23 tentative approvals).
Positive for shareholders — this adds another approved product to Aurobindo's US portfolio, tapping into a sizeable OTC cough-care market and strengthening its US generics pipeline ahead of the Q2FY27 launch.