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.
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.
Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1021.15 as compared to the previous close of Rs. 1017.60. The total number of shares traded during the day was 106740 in over 2157 trades.
The stock hit an intraday high of Rs. 1031.00 and intraday low of 1010.00. The net turnover during the day was Rs. 109031652.00. |