Aurobindo Pharma announced that its wholly owned subsidiary company, Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), PULMICORT RESPULES® (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP.

The product is expected to be launched in FY25.

The approved product has an estimated market size of US$ 226.4 million for the twelve months ending September 2023, according to IQVIA.

This is the 173rd ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile specialty products. Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule is indicated for maintenance treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years.