Aurobindo Pharma Limited has secured a key regulatory win in the United States, receiving final approval from the Food and Drug Administration for its over-the-counter cough treatment.

 

The company will manufacture and market Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC), a product positioned as a bioequivalent alternative to Delsym Extended-Release Oral Suspension. 

 

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation, while also suppressing the urge to cough to aid sleep.

 

Production will take place at the company’s Unit-IV facility under its wholly owned subsidiary, APL Healthcare Limited, with a commercial launch targeted for the second quarter of FY27.

 

The approval gives Aurobindo access to a sizeable U.S. market, estimated at $138 million for the twelve months ending February 2026, according to Nielsen data. It also strengthens the company’s already extensive regulatory track record, bringing its total to 580 ANDA approvals from the USFDA, including 557 final and 23 tentative clearances.

 

Headquartered in Hyderabad, Aurobindo Pharma operates in more than 150 countries and maintains over 30 manufacturing and packaging facilities approved by major global regulators. Its portfolio spans key therapeutic areas including central nervous system disorders, anti-retrovirals, cardiovascular treatments, antibiotics, and anti-diabetic medicines.

 

With this latest approval, the company continues to deepen its footprint in the competitive US generics market, signaling steady momentum in its global expansion strategy.