Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths, a generic equivalent of QVAR® Inhalation Aerosol.
The approval marks Aurobindo Pharma’s first metered-dose inhaler (MDI) product, representing a significant step in its expansion into complex respiratory therapies and strengthening its presence in the inhalation segment.
The product will be manufactured at the company’s Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC, and is expected to be launched in the coming quarters.
According to IQVIA, the US market for the approved product and newer versions of the reference product, QVAR® RediHaler, was estimated at $301 million for the 12 months ended July 2026.
With this approval, Aurobindo Pharma’s cumulative USFDA ANDA approvals have increased to 596, comprising 571 final approvals and 25 tentative approvals.
The company said the approval supports its strategy of expanding beyond conventional generics into complex inhalation therapies, with the aim of creating differentiated growth opportunities in the US market.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma in patients aged five years and older as prophylactic therapy.