BSECompany Update5d ago · 27 Jul 2026, 10:54 pm

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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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Growth Catalyst9/10
Governance Concern1/10
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Liquidity Impact8/10
Market Sentiment9/10

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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