Mumbai, April 20 -- 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, ...