Aurobindo Pharma has secured final approval from the US Food & Drug Administration (USFDA) 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, 30 mg/5 mL, by RB Health (US) LLC.
The manufacturing of this product will take place at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of Aurobindo Pharma, with plans to launch in the second quarter of the fiscal year 2027. The approved product has an estimated market size of US$ 138 million for the twelve months ending February 2026, as per Nielsen data.
This latest approval adds to Aurobindo Pharma’s extensive portfolio, bringing its total to 580 Abbreviated New Drug Application (ANDA) approvals from the USFDA, comprising 557 final approvals and 23 tentative approvals. The Dextromethorphan Polistirex Extended-Release Oral Suspension is designed to temporarily relieve cough due to minor throat and bronchial irritation, as well as suppress the impulse to cough, aiding in sleep.
Aurobindo Pharma, headquartered in Hyderabad, India, operates globally across over 150 countries. It develops, manufactures, and commercialises a broad range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients. The company boasts more than 30 manufacturing and packaging facilities approved by leading regulatory agencies, including the USFDA, UK MHRA, and others.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).