Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, a generic equivalent of Qvar Inhalation Aerosol marketed by Teva Branded Pharmaceutical Products R&D LLC.
The approval represents Hyderabad-based Aurobindo’s first metered-dose inhaler (MDI) product, marking a milestone in the company’s expansion into complex respiratory therapies and strengthening its capabilities in the inhalation segment, the company said in a release on Tuesday.
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 coming quarters. The US market for the approved product and newer versions of the reference product, QVAR® RediHaler, was estimated at $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.
“Building on our leadership in generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market,” the company said.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. It is 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, the released added.
Published on September 15, 2026
