Cipla Limited, along with its wholly owned subsidiary Cipla USA Inc., announced on July 27, 2026, that it has received approval from the United States Food and Drug Administration (FDA) 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).

Key Details of the Approval

The following table summarises the key parameters of this regulatory approval:

A Milestone in Cipla's US Respiratory Portfolio

This approval represents Cipla's first dry powder inhaler (DPI) approval from its US-based manufacturing network, marking a significant milestone in the company's expansion of complex respiratory capabilities in the United States. According to IQVIA, the US market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million, underscoring the commercial significance of this regulatory clearance. The product is backed by Cipla's vertically integrated inhalation platform and reflects the company's commitment to strengthening US manufacturing capabilities for complex respiratory treatments.

Leadership Commentary

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."

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 its home markets of India, South Africa, North America, and key regulated and emerging markets. Key highlights of the company's global presence include:

• 46 manufacturing sites around the world producing 50+ dosage forms and 1,500+ products
• 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)
• 2nd largest by prescription in the US Gx (Repulses + MDI) products (IQVIA MAT Jun'26)
• Strengths in respiratory, antiretroviral, urology, cardiology, anti-infective, and CNS segments

Cipla's product is expected to be launched in Q2 of FY 2026-27 in the United States, further strengthening its presence in the competitive US generics market.

Cipla Limited delivered its highest-ever first-quarter revenue, reporting consolidated sales of ₹7,119 crore for Q1FY27, marking a 2% year-on-year increase. The pharmaceutical major posted a profit after tax (PAT) of ₹789 crore, representing 11% of sales, while maintaining a robust balance sheet with net cash equivalent to ₹9,494 crore as of June 30, 2026. This performance underscores the resilience of Cipla’s diversified portfolio, particularly in its One India business which achieved record quarterly revenue with 12% growth.

The revenue growth was primarily fueled by the branded prescription business in India, which expanded by 15.4% according to IQVIA data. Key therapeutic areas such as anti-diabetes (43% growth), cardiac (20%), and respiratory (15%) contributed significantly to this momentum. Globally, North America generated $162 million in revenue, bolstered by the successful launch of generic Ventolin and continued strength in the albuterol MDI market where Cipla holds a 21% share. However, South Africa faced headwinds from tender losses, though its private market grew 6.5%, outpacing the overall market.

Financial Highlights

Effective April 1, 2026, Cipla revised its financial presentation to treat certain marketing and proportional expenditures as a reduction from revenue rather than operating expenses. This accounting change impacted the reported growth rates; management indicated that adjusted growth would be approximately 4%. The gross margin of 62.5% reflected pressures from product mix shifts, war-related costs estimated at 1-2% of revenue, and inventory write-offs.

Strategic Outlook and Pipeline

Management reaffirmed its target to achieve an exit run rate of $1 billion for the US business by FY27. This trajectory relies on four significant upcoming launches: three respiratory assets, including generic Advair, and one large peptide opportunity. Two of the respiratory filings originate from US manufacturing facilities, while the third is from Goa. The recent US FDA inspection of the Verna, Goa facility was classified as Voluntary Action Indicated (VAI), and a routine inspection at the Invagen facility in New York resulted in one Form 483 observation, which the company is addressing within the stipulated timeline.

In India, the chronic therapy mix strengthened to 60.4% year-on-year. The company added two new brands to its ₹100-plus crore club, bringing the total to 33. New launches such as Duolin Synchrobreathe in respiratory and UPADACIP in immunology are expected to deepen market penetration. For FY27, Cipla maintains its EBITDA margin guidance of 18.5% to 20%, contingent on the successful execution of these new product launches and cost optimization initiatives.