Aurobindo Pharma Gets USFDA Nod for OTC Dextromethorphan Polistirex ER Suspension
New Delhi: Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Dextromethorphan Polistirex Extended-Release Oral Suspension, 30 mg/5 mL (OTC).
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Delsym Extended-Release Oral Suspension, 30 mg/5 mL of RB Health (US) LLC.
The company stated that the product will be manufactured at Unit-IV of APL Healthcare Limited, its wholly owned subsidiary, and is expected to be launched in Q2 FY27.
According to Nielsen data, the approved product has an estimated market size of $138 million for the twelve months ending February 2026. With this approval, Aurobindo Pharma’s cumulative ANDA approvals from the USFDA have reached 580, including 557 final approvals and 23 tentative approvals.
Dextromethorphan Polistirex Extended-Release Oral Suspension is an over-the-counter (OTC) medication indicated for the temporary relief of cough caused by minor throat and bronchial irritation, such as that associated with the common cold or inhaled irritants. It also helps suppress the urge to cough, aiding sleep.
Headquartered in Hyderabad, Aurobindo Pharma is an integrated global pharmaceutical company engaged in the development, manufacturing, and commercialization of generic and specialty pharmaceuticals, as well as active pharmaceutical ingredients (APIs), across more than 150 countries.
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The company operates over 30 manufacturing and packaging facilities worldwide, approved by major regulatory authorities including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. Its portfolio spans key therapeutic areas such as CNS, anti-retroviral, cardiovascular, antibiotics, gastroenterological, anti-diabetic, and anti-allergic segments, supported by a strong research and development framework.
