Product Approval Details

Aurobindo Pharma Limited received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg. This product is a generic equivalent of QVAR® Inhalation Aerosol 40 mcg and 80 mcg, which is marketed by Teva Branded Pharmaceutical Products R&D LLC.

Strategic Significance

  • This represents Aurobindo's first metered-dose inhaler (MDI) product
  • Marks a significant milestone in the Company's expansion into complex respiratory therapies
  • Strengthens the company's capabilities in the inhalation segment
  • Part of the strategy to create the next wave of differentiated growth in the US market

Manufacturing and Launch Details

  • The product will be manufactured at Aurobindo Pharma's Raleigh facility in North Carolina
  • The facility is owned by the company's wholly owned step-down subsidiary Aurolife Pharma LLC
  • The product is expected to be launched in upcoming quarters

Market Opportunity

  • The US market for the approved product and newer versions of the reference product (QVAR® RediHaler) was estimated at US$301 million
  • Market data covers the twelve months ended July 2026

Regulatory Portfolio Update

  • With this approval, Aurobindo Pharma's cumulative USFDA ANDA approvals stand at 596
  • This comprises 571 final approvals and 25 tentative approvals
  • Further strengthens the Company's portfolio of complex and differentiated products

Therapeutic Indication

Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. It is specifically 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.

Company Background

Aurobindo Pharma Limited 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. The company has 30+ manufacturing and packaging facilities approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA.