Cipla Secures FDA Nod for First U.S.-Made Dry Powder Inhaler to Rival Advair

Strategic Expansion into the U.S. Inhalation Market

Cipla has achieved a regulatory milestone with the U.S. Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for a generic version of the asthma and COPD treatment, Advair Diskus. This clearance covers fluticasone propionate and salmeterol inhalation powder across three specific strengths: 100/50 mcg, 250/50 mcg, and 500/50 mcg.

This development signifies the first dry powder inhaler (DPI) approval sourced from Cipla’s domestic manufacturing infrastructure in the United States. Management confirmed on Monday that the commercial rollout is scheduled for the second quarter (Q2) of FY27.

Targeting a $908 Million Respiratory Sector

The generic product serves as a therapeutic equivalent to the reference brand, a combination therapy frequently prescribed for managing chronic obstructive pulmonary disease (COPD) and asthma. Market data from IQVIA estimates the total U.S. market for this specific inhalation powder at approximately $908 million.

Manufacturing and Operational Impact

• Production Hub: The inhalers will be produced at Cipla's New York facility, representing a shift toward localized production of complex therapies.
• Strategic Focus: Marc Falkin, CEO of Cipla North America, noted that the approval validates the firm's investments in specialized inhalation manufacturing within the U.S.
• Portfolio Growth: Global CEO Achin Gupta stated that the move strengthens the company's ability to scale sophisticated medical products through integrated capabilities.

By securing this approval, Cipla positions itself to compete in a high-value segment while diversifying its North American portfolio with differentiated drug delivery systems.

Source: The Hindu — Business