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Cipla Secures USFDA Nod for First Interchangeable Generic of Ventolin HFA

Pharm'Up 1 min read

Cipla Limited has reached a pivotal milestone in the respiratory healthcare sector, announcing USFDA approval for the first AB-rated generic version of GlaxoSmithKline’s Ventolin® HFA (Albuterol Sulfate Inhalation Aerosol, 90 mcg).

This approval is a strategic “double-win” for the company. Cipla now holds approved generics for both major brands, Ventolin® HFA and Proventil® HFA, effectively cornering a significant portion of the $1.5 billion U.S. albuterol market.

Domestic Production and Patient Impact

In a move to ensure supply chain stability, Cipla North America CEO Marc Falkin confirmed the product will be manufactured at their Fall River, Massachusetts facility. This domestic footprint is designed to prevent shortages of the life-saving rescue medication, which is used by millions to treat bronchospasm and exercise-induced asthma.

Global CEO Achin Gupta highlighted that the achievement underscores Cipla’s “strong scientific and regulatory capabilities,” particularly in the complex field of inhalation therapies where the device’s precision is just as critical as the medicine itself.

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