Aurobindo Pharma receives final USFDA approval for generic Beclomethasone inhalation Aerosol

Aurobindo Pharma's first metered-dose inhaler marks a major step into complex respiratory treatments

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and distribute its generic Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg doses. The approved product serves as a generic alternative to Teva Branded Pharmaceutical Products' QVAR Inhalation Aerosol.

This represents Aurobindo’s first metered-dose inhaler (MDI) product, marking a significant milestone in the Company’s expansion into complex respiratory therapies and strengthening its capabilities in the inhalation segment. The product will be manufactured at Aurobindo Pharma’s Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. The product is expected to be launched in upcoming quarters.

The US market for the approved product and newer versions of the reference product, QVAR RediHaler, was estimated at US$301 million for the twelve months ended July 2026, according to IQVIA.

With this approval, Aurobindo Pharma’s cumulative USFDA ANDA approvals stand at 596, comprising 571 final approvals and 25 tentative approvals, further strengthening the Company’s portfolio of complex and differentiated products.

Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Indicated for asthma patients who require systemic corticosteroid administration, where adding Beclomethasone Dipropionate HFA Inhalation Aerosol may reduce or eliminate the need for the systemic corticosteroids.