The approval covers Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths. The product is a generic equivalent of QVAR Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC.
The inhaler is used as a maintenance treatment to help control asthma symptoms and improve breathing. It is indicated for patients aged five years and older and is intended for those who require regular preventive treatment for asthma.
The product will be manufactured at Aurobindo Pharma’s Raleigh facility in North Carolina. The plant is owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma. The company expects to launch the product in the coming quarters.
US market opportunity
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.
The approval marks Aurobindo Pharma’s entry into metered-dose inhalers and expands its portfolio of complex respiratory therapies. The company said the move would strengthen its capabilities in the inhalation segment.
Following the approval, Aurobindo Pharma’s cumulative USFDA abbreviated new drug application (ANDA) approvals stand at 596, including 571 final approvals and 25 tentative approvals.
Raleigh facility clears inspection
The approval comes after a key regulatory update concerning the company’s Raleigh facility. Last month, the USFDA issued an Establishment Inspection Report (EIR) for the plant, formally closing the inspection.
The US regulator had inspected the facility from March 24 to April 10, 2025. The inspection covered the plant’s manufacturing operations for inhalers, dermatology products and transdermal products.
At the end of the inspection, the USFDA had issued a Form 483 containing 11 observations. The subsequent EIR marked the formal closure of the inspection process.
Another USFDA inspection ends with zero observations
Aurobindo Pharma also reported a positive regulatory update last week involving its wholly owned subsidiary, Apitoria Pharma Private Ltd.
The USFDA inspection at Unit-IV of Apitoria Pharma concluded with zero observations on September 11, 2026. The inspection was conducted from September 7 to September 11 at the company’s active pharmaceutical ingredient (API) manufacturing facility in Pydibhimavaram, in Andhra Pradesh’s Srikakulam district.
The outcome adds to a series of regulatory developments for Aurobindo Pharma as it continues to strengthen its manufacturing base and expand its product portfolio across regulated markets.
The company had also reported a stronger-than-expected June quarter, with profit, revenue and operating margin beating Street estimates. Growth during the quarter was led by Europe, growth markets and the US, while management said strategic investments continued to support its long-term expansion plans.
