Aurobindo Pharma has received final approval from the US Food and Drug Administration (FDA) 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 USD 301 million for the 12 months ended July 2026, according to IQVIA.

With this approval, the company’s cumulative FDA 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 its leadership in generics, the company is now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market.

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