Aurobindo Pharma Secures USFDA Approval for Dextromethorphan Extended-Release Oral Suspension
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market its Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC). The product is recognized as being both bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym Extended-Release Oral Suspension, 30 mg/5 mL, originally marketed by RB Health (US) LLC.The approved product is scheduled for launch in Q2FY27 and will be manufactured at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the company.
The OTC suspension is indicated to temporarily relieve minor coughs caused by throat and bronchial irritation, such as those associated with the common cold or inhaled irritants, and also targets the impulse to cough to help an individual get to sleep.
Market Potential and Company Milestones
The approved product enters a market estimated to have a size of US$ 138 million for the twelve months ending February 2026, according to Nielsen.With this approval, Aurobindo Pharma Ltd. has amassed a total of 580 ANDA approvals from the USFDA, comprising 557 final approvals and 23 tentative approvals.
The company, an integrated global pharmaceutical player headquartered in Hyderabad, India, develops, manufactures, and commercializes a range of generic pharmaceuticals and branded specialty pharmaceuticals across more than 150 countries. The company utilizes its robust product portfolio across seven major therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and AntiAllergic.
For a detailed overview of the company’s operational history and product segments, the company reported the following key metrics:
| Metric | Count / Value |
|---|---|
| Total ANDA Approvals | 580 |
| Final Approvals | 557 |
| Tentative Approvals | 23 |
| Market Size Estimate (12 months ending Feb 2026) | US$ 138 million |
AUROPHARMA Stock Price Movement
Today, Aurobindo Pharma Limited shares slipped by 0.11% to settle at ₹1386.0, concluding trading post-market. Despite hitting a 52-week high of ₹1394.9, the stock saw a total volume of 1.61 million shares traded today.Source:
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