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