Aurobindo Pharma Gets USFDA Nod for First Metered-Dose Inhaler, Beclomethasone Aerosol
New Delhi: Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration (USFDA) 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.
The approval marks Aurobindo Pharma’s first metered-dose inhaler (MDI) product and represents a milestone in the company’s expansion into complex respiratory therapies and 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 the upcoming quarters.
According to IQVIA data cited by the company, the U.S. market for the approved product and newer versions of the reference product, QVAR® RediHaler, was estimated at US$301 million for the 12 months ended July 2026.
With the latest approval, Aurobindo Pharma’s cumulative USFDA ANDA approvals stand at 596, comprising 571 final approvals and 25 tentative approvals, further expanding its portfolio of complex and differentiated products.
“Building on our leadership in Generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market,” the company said.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 5 years and older. It is indicated for asthma patients who require systemic corticosteroid administration, where adding Beclomethasone Dipropionate HFA Inhalation Aerosol may reduce or eliminate the need for systemic corticosteroids.
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures and commercializes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in more than 150 countries.
The company has more than 30 manufacturing and packaging facilities approved by leading regulatory agencies, including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC and Brazil ANVISA. Its product portfolio covers seven major therapeutic/product areas, including CNS, anti-retroviral, CVS, antibiotics, gastroenterology, anti-diabetics and anti-allergics, supported by its R&D operations.
