Hyderabad, Nov 30 – Hyderabad-based Aurobindo Pharma Limited on Thursday said 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.
Ampule is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), PULMICORT RESPULES® (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP, the pharma company said in a release here.
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.
Aurobindo Pharma which is an integrated global pharmaceutical company , has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.
The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
