Cipla Limited and its wholly owned subsidiary Cipla USA Inc. have secured final approval from the U.S. Food and Drug Administration (USFDA) for their Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. The approval marks a significant milestone as it introduces the first AB-rated generic equivalent of Ventolin HFA, a widely used inhaler marketed by GlaxoSmithKline.
The newly approved inhaler is indicated for treating or preventing bronchospasm in adults and children aged four years and older suffering from reversible obstructive airway diseases, such as asthma. It is also approved for preventing exercise-induced bronchospasm in the same age group. With respiratory conditions affecting millions in the United States, the introduction of a cost-effective generic alternative is expected to improve accessibility for patients.
According to industry data from IQVIA, the U.S. market for albuterol inhalers is valued at approximately $1.5 billion, underscoring the commercial significance of this approval. Cipla’s entry with a therapeutically equivalent generic version positions the company to capture a share of this substantial market.
The approval further strengthens Cipla’s respiratory portfolio in the U.S., where it already offers generic alternatives to both Ventolin HFA and Proventil HFA inhalers. Company leadership highlighted the achievement as a testament to its expertise in developing complex inhalation therapies.
Achin Gupta, Managing Director and Global CEO of Cipla Limited, emphasized that the milestone reflects the company’s robust scientific and regulatory capabilities. He noted that lung health remains central to Cipla’s strategy, with a focus on building a sustainable and differentiated global portfolio.
Meanwhile, Marc Falkin, CEO of Cipla North America, stated that the product will be manufactured at the company’s dedicated inhalation facility in Fall River, Massachusetts. The facility represents Cipla’s ongoing investment in U.S.-based manufacturing and is expected to enhance supply reliability while supporting domestic production.
With plans to scale up production, Cipla aims to make a meaningful impact on patient access to essential respiratory treatments, reinforcing its growing presence in the U.S. generics market.