MUMBAI, India and WARREN, N.J., July 28, 2026
Cipla Limited and its wholly owned subsidiary Cipla USA Inc. have received U.S. Food and Drug Administration (FDA) approval for the company’s Abbreviated New Drug Application (ANDA) for the generic version of Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) in all three approved strengths—100/50 mcg, 250/50 mcg, and 500/50 mcg. The approval marks a major milestone for the global pharmaceutical company, representing its first dry powder inhaler (DPI) approval manufactured through its U.S.-based manufacturing network. The newly approved product is therapeutically equivalent to Advair Diskus®, one of the most widely prescribed inhalation therapies for asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is valued at approximately $908 million, highlighting the significant commercial opportunity created by this approval. The milestone further strengthens Cipla’s leadership in respiratory medicine, expands patient access to affordable inhalation therapies, and reinforces the company’s long-term commitment to developing complex generic respiratory products for the U.S. healthcare market.
FDA Approval Expands Cipla’s Respiratory Medicine Portfolio
The FDA approval enables Cipla to market a therapeutically equivalent generic alternative to Advair Diskus®, a combination inhalation therapy widely used for the long-term treatment of asthma and COPD. The product combines fluticasone propionate, an inhaled corticosteroid that reduces airway inflammation, with salmeterol, a long-acting beta-agonist that helps maintain open airways, providing effective maintenance therapy for millions of patients suffering from chronic respiratory diseases. Approval across all three dosage strengths significantly enhances treatment flexibility while increasing the availability of lower-cost therapeutic options for patients and healthcare providers. The approval also reflects Cipla’s growing expertise in developing complex inhalation products, an area requiring advanced formulation science, sophisticated device engineering, and stringent manufacturing quality standards. By expanding its respiratory portfolio, Cipla continues to reinforce its position as one of the world’s leading manufacturers of innovative and affordable inhalation therapies.
U.S. Manufacturing Capability Reaches Major Milestone
A key highlight of the approval is that it represents Cipla’s first dry powder inhaler manufactured through its U.S.-based production network, demonstrating the company’s successful investment in expanding advanced pharmaceutical manufacturing capabilities within the United States. The product will be produced through Cipla’s integrated inhalation manufacturing platform, supporting reliable domestic production while strengthening supply chain resilience for complex respiratory medicines. Achin Gupta, Managing Director and Global Chief Executive Officer of Cipla Limited, stated that the approval reinforces the company’s longstanding commitment to respiratory care and reflects its ability to develop and scale sophisticated inhalation therapies. Marc Falkin, Chief Executive Officer of Cipla North America, emphasized that the milestone showcases the company’s strategic investments in its New York manufacturing facility, enhancing its ability to deliver consistent, high-quality respiratory medicines while competing effectively within the rapidly growing U.S. inhalation market. The approval demonstrates Cipla’s vertically integrated capabilities spanning product development, manufacturing, quality assurance, and commercial supply.
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Strengthening Access to Affordable Respiratory Treatments
The approval further advances Cipla’s global strategy of improving patient access to high-quality generic medicines while expanding its presence in complex pharmaceutical categories. Respiratory diseases such as asthma and COPD continue to represent major public health challenges worldwide, creating sustained demand for reliable and affordable maintenance therapies. By introducing a generic equivalent to one of the market’s leading inhalation products, Cipla has the opportunity to enhance treatment accessibility while supporting healthcare systems seeking cost-effective alternatives without compromising therapeutic quality. The achievement also reinforces the company’s growing reputation as a global leader in complex generic drug development, particularly in inhalation technologies that require specialized formulation expertise and advanced manufacturing infrastructure. With continued investments in innovation, respiratory science, and U.S.-based production capabilities, Cipla is well positioned to expand its footprint in the competitive respiratory therapeutics market while delivering long-term value to patients, healthcare providers, and the broader pharmaceutical industry.
Source: Cipla press release
