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- Aurobindo Pharma received final FDA approval for Beclomethasone Dipropionate HFA Inhalation Aerosol 40 mcg and 80 mcg, its first metered-dose inhaler product. - The product is a generic equivalent of Teva's QVAR Inhalation Aerosol and is indicated for maintenance treatment of asthma as prophylactic therapy. - Manufacturing will take place at Aurolife Pharma's Raleigh, North Carolina facility, with launch expected in upcoming quarters. - Aurobindo cited IQVIA data estimating the U.S. market for the product and newer versions of the reference product at $301 million for the 12 months ended July 2026.
- Aurobindo Pharma's subsidiary Aurolife Pharma received 11 procedural observations from the US FDA following an 18-day inspection of its North Carolina facility. - The inspection, conducted from March 24 to April 10, 2025, focused on the facility's manufacturing of inhalers and dermatological products. - Aurobindo has committed to submitting a comprehensive response with corrective and preventive action plans, stating the observations will not impact ongoing operations or product supply.
