Aurobindo Pharma USFDA Approval for $138M Cough Syrup

Aurobindo Pharma received USFDA final approval for Dextromethorphan Polistirex Extended-Release Oral Suspension, an OTC cough syrup.
The product has an estimated market size of US$ 138 million and is bioequivalent to Delsym by RB Health.
Manufacturing will occur at APL Healthcare Limited subsidiary with planned Q2FY27 launch.
This brings Aurobindo's total ANDA approvals to 580 (557 final, 23 tentative).