Aurobindo Pharma gets USFDA nod for Dextromethorphan Oral Suspension

The product is 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.

The approved formulation is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Delsym extended-release oral suspension, 30 mg/5 mL, marketed by RB Health (US) LLC.

Aurobindo Pharma said the product will be manufactured at Unit IV of APL Healthcare, its wholly owned subsidiary, and is expected to be launched in Q2 FY27.

According to Nielsen data for the 12 months ended February 2026, the product has an estimated market size of $138 million. With this approval, the company now has a total of 580 ANDA approvals from the USFDA, including 557 final approvals and 23 tentative approvals.

The official announcement was made on 17 April 2026, after market hours.

Aurobindo Pharma is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services. The company reported a 7.6% rise in consolidated net profit to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25.

The counter shed 0.62% to Rs 1,377 on the BSE.