Cipla Receives U.S. FDA Approval for Generic Advair Diskus® in Three Strengths

Cipla Receives U.S. FDA Approval for Generic Advair Diskus® in Three Strengths​

Mumbai and Warren, New Jersey, USA - July 27, 2026 - Cipla Limited today announced that it has secured approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). The application was for Generic Advair Diskus®, a fluticasone propionate and salmeterol inhalation powder.

The FDA granted approval for all three strengths of the product: 100/50 mcg, 250/50 mcg, and 500/50 mcg. Generic Advair Diskus® is a therapeutically equivalent combination therapy intended for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Market Significance and Expansion​

The approval marks a key milestone for Cipla, representing the company's first dry powder inhaler (DPI) approval originating from its U.S.-based manufacturing network. This achievement is vital as it strengthens the company’s commitment to expanding complex respiratory capabilities in the United States market.

According to data from IQVIA, the U.S. market specifically for fluticasone propionate and salmeterol inhalation powder is approximately $908 million.

Cipla North America noted that this approval reflects targeted investments aimed at building differentiated inhalation manufacturing capacities within the U.S., strengthening its ability to provide reliable, high-quality supply in a competitive category.

Commitment to Respiratory Care​

Commenting on the significance of the FDA endorsement, Achin Gupta, Managing Director and Global CEO of Cipla Limited, stated that the approval reinforces the company’s commitment to expanding access to complex therapies in the U.S. It also highlights Cipla’s strength in developing and scaling sophisticated inhalation products through integrated capabilities.

The product is backed by Cipla's vertically integrated inhalation platform and reflects the company's dedication to strengthening its U.S. manufacturing capabilities for complex respiratory treatments.

Company Overview​

Cipla, established in 1935, operates as a global pharmaceutical company with strengths across respiratory, antiretroviral, urology, cardiology, anti-infective, and CNS segments. The company has 46 manufacturing sites worldwide, producing over 1,500 products across more than 70 markets.

Key market rankings provided by IQVIA include:

CIPLA Stock Price Movement​

On Monday, shares of Cipla Limited edged higher, gaining 0.31% in the session to settle at ₹1415. The stock saw notable trading activity as 1.16 million shares were exchanged during the market phase.