Aurobindo Pharma Secures USFDA Approval for Cough Relief Suspension
Aurobindo Pharma gets USFDA nod for Dextromethorphan Oral Suspension
Business Standard
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Aurobindo Pharma has received approval from the US Food and Drug Administration (USFDA) for its Dextromethorphan Polistirex extended-release oral suspension, aimed at providing temporary cough relief. The product, expected to launch in Q2 FY27, has a market size of approximately $138 million.
- 01Aurobindo Pharma's Dextromethorphan oral suspension receives USFDA approval.
- 02The product is intended for temporary relief of cough associated with minor throat irritation.
- 03It will be manufactured at APL Healthcare's Unit IV and is set to launch in Q2 FY27.
- 04The market size for this product is estimated at $138 million.
- 05Aurobindo Pharma has a total of 580 ANDA approvals from the USFDA.
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Aurobindo Pharma, a major player in the pharmaceutical industry, has announced that it has received approval from the US Food and Drug Administration (USFDA) for its Dextromethorphan Polistirex extended-release oral suspension, dosed at 30 mg/5 mL. This over-the-counter product is designed to offer temporary relief from coughs caused by minor throat and bronchial irritation, particularly those associated with the common cold or inhaled irritants. The formulation is bioequivalent and therapeutically equivalent to the reference listed drug, Delsym, marketed by RB Health (US) LLC. The product will be manufactured at APL Healthcare's Unit IV and is expected to be launched in the second quarter of fiscal year 2027. According to Nielsen data, the estimated market size for this product is around $138 million. Following this approval, Aurobindo Pharma has achieved a total of 580 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which includes 557 final approvals and 23 tentative approvals. The announcement was made on April 17, 2026, after market hours, and Aurobindo Pharma reported a 7.6% increase in consolidated net profit to βΉ910.29 crore for the third quarter of fiscal year 2026 compared to the same period last year.
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The approval of this cough relief product could enhance Aurobindo Pharma's market presence and revenue, potentially benefiting consumers seeking effective over-the-counter cough remedies.
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