NSEPress Release4d ago · 15 Sept 2026, 01:03 pm
Press Release
Aurobindo Pharma Limited · AUROPHARMA
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Aurobindo Pharma Limited has received final approval from the US FDA 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. This represents Aurobindo’s first metered-dose inhaler (MDI) product, marking a significant milestone in the Company’s expansion into complex respiratory therapies.
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Aurobindo Pharma Limited has informed the Exchange regarding a press release dated September 15, 2026, titled "Aurobindo Pharma receives USFDA Final Approval for Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg".
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September 15, 2026
To To
Listing Department, The Corporate Relations Department
NATIONAL STOCK EXCHANGE OF INDIA LIMITED BSE LIMITED
Exchange Plaza, Bandra Kurla Complex,Bandra (E), Phiroz Jeejeebhoy Towers, 25th floor, Dalal Street,
MUMBAI -400 051 MUMBAI -400 001
Company Code No. AUROPHARMA Company Code No. 524804
Dear Sir/ Madam,
Sub: Press Release - Aurobindo Pharma receives USFDA Final Approval for Beclomethasone Dipropionate
HFA Inhalation Aerosol, 40 mcg and 80 mcg
We enclose a copy of the Press Release that is being issued by the Company in connection with receipt of
USFDA Final approval for Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg.
Please take the information on record.
Thanking you,
Yours faithfully,
For AUROBINDO PHARMA LIMITED
B. Adi Reddy
Company Secretary
Encl: as above
Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India.
Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044.
Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833
Email: info@aurobindo.com Website: www.aurobindo.com
Press Release
Hyderabad, India, September 15, 2026
Aurobindo Pharma receives USFDA Final Approval for Beclomethasone Dipropionate HFA
Inhalation Aerosol, 40 mcg and 80 mcg
Aurobindo Pharma Limited today announced that it has received final approval from the US Food & 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.
This represents Aurobindo’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 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 upcoming quarters.
The US market for the approved product and newer versions of the reference product, QVAR®
RediHaler, was estimated at US$301 million for the twelve months ended July 2026, according to IQVIA.
With this approval, Aurobindo Pharma’s cumulative USFDA ANDA approvals stand at 596, comprising
571 final approvals and 25 tentative approvals, further strengthening the Company’s 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.
Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of
asthma as prophylactic therapy in patients 5 years of age and older. 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.
About Aurobindo Pharma Limited
Aurobindo Pharma Limited (www.aurobindo.com), (NSE: AUROPHARMA, BSE: 524804, Reuters:
ARBN.NS, Bloomberg: ARBP IN) 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 that are approved by leading regulatory
agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC,
Brazil ANVISA. The Company’s robust product portfolio is spread over seven major therapeutic/product
areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-
Allergic, supported by a strong R&D set-up.
Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India.
Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044.
Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833
Email: info@aurobindo.com Website: www.aurobindo.com
To know more, please log on to www.aurobindo.com
For further information or queries, please contact:
Investor Relations | Corporate Communications
Phone: +91 40 66751211 | 66725000
Email: ir@aurobindo.com
Disclaimer:
This press release contains statements that may constitute “forward looking statements” including and
without limitation, statements relating to product characteristics and uses, sales potential and target
dates for product launch, implementation of strategic initiatives, and other statements relating to our
future business developments and economic performance. While these forward-looking statements
represent our judgment and future expectations concerning the development of our business, a
number of risks, uncertainties and other factors could cause actual developments and results to differ
materially from our expectations. The company undertakes no obligation to publicly revise any
forward-looking statements to reflect future events or circumstances and will not be held liable for any
use of this information.
Corp. Off.: Galaxy, Floors: 22-24, Plot No.1, Survey No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha, Ranga Reddy District, Hyderabad – 500 032, Telangana, India.
Tel : +91 40 6672 5000 / 6672 1200 Fax: +91 40 6707 4044.
Regd. off.: Plot No. 2, Maithrivihar, Ameerpet, Hyderabad - 500 038, Telangana., India. Tel: +91 40 2373 6370/ 2374 7340 Fax: +91 40 2374 1080 / 2374 6833
Email: info@aurobindo.com Website: www.aurobindo.com