Hyderabad-based Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) on September 15, 2026, to manufacture and market its first metered-dose inhaler for asthma treatment in the United States. The approval covers Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths. This represents Aurobindo Pharma'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 is a generic equivalent of QVAR Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC. Despite the positive regulatory development, Aurobindo Pharma shares came under pressure on Tuesday, closing 1.18% lower as the company announced the approval.
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 is 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. 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 product will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma. Aurobindo expects to launch the product in the upcoming quarters.
The approval comes after a key regulatory update concerning the company's Raleigh facility. According to CNBC TV18, 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, covering 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, with the subsequent EIR marking the formal closure of the inspection process.
The approval marks Aurobindo Pharma's entry into metered-dose inhalers and expands its portfolio of complex respiratory therapies. Following the approval, Aurobindo Pharma's cumulative USFDA abbreviated new drug application (ANDA) approvals stand at 596, comprising 571 final approvals and 25 tentative approvals. The asthma maintenance therapy will be produced at Aurobindo's Raleigh, North Carolina facility through subsidiary Aurolife Pharma LLC. The company stated it is expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market. The addition of this product strengthens Aurobindo Pharma's portfolio of complex and differentiated products, with the $301 million market size for the approved product indicating a significant revenue opportunity for the company's first foray into metered-dose inhalers.
The approval comes after Aurobindo Pharma reported a stronger-than-expected June quarter, with profit, revenue and operating margin beating Street estimates. According to CNBC TV18, 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. The company's consolidated net profit jumped 25.20% to ₹1,032.56 crore on a 16.86% increase in revenue to ₹9,105.82 crore in Q1 FY27 as compared with Q1 FY26. The latest approval marks Aurobindo's entry into the metered-dose inhaler segment, though the commercial impact will depend on the product's launch timeline and performance in the US market.
