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Cipla Ltd · 500087
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Cipla Ltd has received US FDA approval for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus in all three strengths, marking a significant milestone in the company's expansion of complex respiratory capabilities in the US.
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Cipla Ltd - 500087 - Cipla Receives U.S. FDA Approval For Generic Advair Diskus®
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27th July, 2026
(1) BSE Limited (2) National Stock Exchange of India Limited
Listing Department, Listing Department
Phiroze Jeejeebhoy Towers, Exchange Plaza, 5th floor,
Dalal Street, Plot no. C/1, G Block,
Mumbai 400 001 Bandra Kurla Complex,
Bandra (East), Mumbai - 400 051
Scrip Code: 500087 Scrip Code: CIPLA
(3) SOCIETE DE LA BOURSE DE LUXEMBOURG
Societe Anonyme
35A Boulevard Joseph II,
L-1840 Luxembourg
Dear Sir/Madam,
Sub: Cipla Receives U.S. FDA Approval for Generic Advair Diskus®
Pursuant to the provisions of Regulation 30 read with Schedule III Part A Para B of the SEBI (Listing
Obligations and Disclosure Requirements) Regulations, 2015 and the SEBI circular no.
HO/49/14/14(7)2025-CFD-POD2/I/3762/2026 dated 30th January 2026, we hereby notify that the
Company has received approval from the United States Food and Drug Administration (‘USFDA’) for the
Abbreviated New Drug Application (‘ANDA’) submitted for Generic Advair Diskus® (fluticasone
propionate and salmeterol inhalation powder) in all three strengths—100/50 mcg, 250/50 mcg, and
500/50 mcg.
The product is a therapeutically equivalent version of Advair Diskus®, a widely prescribed combination
therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
The product is expected to be launched in Q2 of FY 2026-27 in the United States of America.
A press release dated 27th July 2026 on the captioned subject is also enclosed.
Please take the above information on record.
Yours faithfully,
For Cipla Limited
Rajendra Chopra
Company Secretary
Prepared by: Chirag Hotchandani
Encl: a/a
Cipla Ltd .
Regd. Office - Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400 013, India
P +91 22 41916000 W www.cipla.com E-mail contactus@cipla.com Corporate Identity Number L24239MH1935PLC002380
Cipla Receives U.S. FDA Approval for Generic Advair Diskus®
(Fluticasone Propionate and Salmeterol Inhalation Powder), across all three
strengths
Mumbai, India and Warren, New Jersey, USA – July 27, 2026 - Cipla Limited (BSE:
500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") and its wholly owned
subsidiary Cipla USA Inc., (hereafter referred to as “Cipla”), today announced that
Cipla Limited has received U.S. Food and Drug Administration (FDA) approval for its
Abbreviated New Drug Application (ANDA) for Generic Advair Diskus® (fluticasone
propionate and salmeterol inhalation powder) in all three strengths—100/50 mcg,
250/50 mcg, and 500/50 mcg.
The product is a therapeutically equivalent version of Advair Diskus®, a widely
prescribed combination therapy indicated for the treatment of asthma and chronic
obstructive pulmonary disease (COPD). According to IQVIA, the U.S. market for
fluticasone propionate and salmeterol inhalation powder is approximately $908
million. This approval represents Cipla’s first dry powder inhaler (DPI) approval from its
U.S.-based manufacturing network, marking a significant milestone in the company’s
continued expansion of complex respiratory capabilities in the United States.
Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla
Limited, said: “At Cipla, we’re passionate about respiratory care given our long-
standing expertise. This approval reinforces our commitment to expanding access to
complex therapies in the U.S. and highlights our strength in developing and scaling
sophisticated inhalation products through integrated capabilities.”
Backed by Cipla’s vertically integrated inhalation platform, the product reflects the
company’s commitment to strengthening U.S. manufacturing capabilities for complex
respiratory treatments.
Marc Falkin, Chief Executive Officer, Cipla North America, added: “This approval
marks our first dry powder inhaler from our New York facility and reflects our targeted
investments in building differentiated inhalation manufacturing capabilities in the U.S.
It strengthens our ability to provide reliable, high-quality supply in an important and
competitive category”
About Cipla Limited
Established in 1935, Cipla is a global pharmaceutical company focused on agile and
sustainable growth, complex generics, and deepening portfolio in our home markets
of India, South Africa, North America, and key regulated and emerging markets. Our
strengths in the respiratory, antiretroviral, urology, cardiology, anti-infective and CNS
segments are well-known. Our 46 manufacturing sites around the world produce 50+
dosage forms and 1,500+ products using cutting-edge technology platforms to cater
to our 70+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Jun’26),
2nd Largest in the pharma prescription market in South Africa (IQVIA MAT May’26), and
2nd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Jun’26).
For nine decades, making a difference to patients has inspired every aspect of Cipla’s
work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at
less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed
to bringing inclusiveness, accessibility and affordability to the center of the HIV
movement. A responsible corporate citizen, Cipla’s humanitarian approach to
healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community
links wherever it is present make it a partner of choice to global health bodies, peers
and all stakeholders. For more, please visit www.cipla.com, or click
on Twitter, Facebook, LinkedIn.
Corporate Communications Investor Relations
Heena Kanal Diksha Maheshwari
CorpComm@cipla.com investorrelations@cipla.com