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Aurobindo Pharma gets USFDA’s nod for Beclomethasone Dipropionate HFA Inhalation Aerosol
Sep-15-2026

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg, a generic equivalent of QVAR Inhalation Aerosol 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC.

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 $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. 

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments. 


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