The product is expected to be launched in FY25
Aurobindo Pharma Limited's 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 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.
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