The approved ANDA is a generic equivalent of QVAR Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC.

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.

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 an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.

Aurobindo Pharma is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services.

The company's consolidated net profit jumped 25.20% to Rs 1032.56 crore on a 16.86% increase in revenue to Rs 9,105.82 crore in Q1 FY27 as compared with Q1 FY26.

The scrip fell 1.15% to currently trade at Rs 465 on the BSE.