15-Sept-2026 13:04:38
AUROPHARMAGeneral news
AUROBINDO PHARMA : USFDA APPROVES FIRST MDI PRODUCT FOR RESPIRATORY THERAPIES
• Aurobindo Pharma received final USFDA approval for Beclomethasone Dipropionate HFA Inhalation Aerosol (40 mcg and 80 mcg). • This marks the company's first metered-dose inhaler (MDI) product, expanding capabilities in complex respiratory therapies. • The product will be manufactured at its US facility, owned by step-down subsidiary Aurolife Pharma LLC. • The US market for the approved product was estimated at US$301 million for the twelve months ended July 2026. • Aurobindo Pharma's cumulative USFDA ANDA approvals stand at 596 (571 final, 25 tentative). • Impact: Positive (First MDI product approval from USFDA strengthens capabilities in complex respiratory therapies)
Aurobindo Pharma Limited
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