Aurobindo Pharma Limited on Thursday announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, 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 company announced through an exchange filing.
The product is expected to be launched in FY25. The approved product has an estimated market size of US dollar 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.
Aurobindo Pharma Limited shares
The shares of Aurobindo Pharma Limited on Thursday at 11:30 am IST were trading at Rs 1,039.40, up by 1.76 percent.
