Aurobindo Pharma has received final approval from the USFDA to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg. This marks the company’s first metered-dose inhaler product, expanding its complex respiratory therapies. The product is a generic equivalent of QVAR® Inhalation Aerosol and will be manufactured at Aurobindo’s facility in North Carolina. This approval strengthens Aurobindo’s cumulative USFDA ANDA approvals to 596.
USFDA Approval for Beclomethasone Dipropionate HFA Inhaler
Aurobindo Pharma Limited announced on September 15, 2026, that it has secured final approval from the U.S. Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, available in 40 mcg and 80 mcg strengths. This product is a generic equivalent to QVAR® Inhalation Aerosol 40 mcg and 80 mcg.
Milestone in Respiratory Therapies
This approval signifies a major milestone for Aurobindo Pharma as it represents their first metered-dose inhaler (MDI) product. The launch of this product marks a significant expansion into complex respiratory therapies and enhances the company’s capabilities within the inhalation segment. Production of the inhaler will take place at Aurobindo Pharma’s facility in Raleigh, North Carolina, operated by its subsidiary, Aurolife Pharma LLC. The product is anticipated to be launched in the upcoming quarters.
Market Potential and Portfolio Growth
The U.S. market for the approved product and related versions of the reference product, QVAR® RediHaler, was valued at approximately US$301 million for the twelve months ending July 2026, according to IQVIA data. With this latest approval, Aurobindo Pharma’s total cumulative USFDA ANDA (Abbreviated New Drug Application) approvals have reached 596, comprising 571 final approvals and 25 tentative approvals. This further strengthens the company’s diverse portfolio of complex and differentiated products.
Strategic Expansion into Inhalation Therapies
Building on its established leadership in generics, Aurobindo Pharma is strategically expanding into complex inhalation therapies to drive future growth in the U.S. market. Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as a prophylactic therapy for patients aged 5 years and older. It is particularly beneficial for asthma patients requiring systemic corticosteroid treatment, as its use may help reduce or eliminate the need for such systemic medications.
Company Background
Aurobindo Pharma Limited, headquartered in Hyderabad, India, is an integrated global pharmaceutical company. It develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients across more than 150 countries. The company boasts over 30 manufacturing and packaging facilities approved by major regulatory agencies worldwide, including the USFDA, UK MHRA, and others. Its product portfolio spans seven major therapeutic areas, supported by a robust Research and Development setup.
Source: BSE
