Pharma powerhouse Cipla has secured final approval from the US FDA for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation—marking a major milestone in the company’s US respiratory strategy.

 

The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline, in a market estimated at around $1.5 billion in the United States, according to IQVIA.

 

The inhalation aerosol is indicated for the treatment and prevention of bronchospasm in adults and children aged four years and older with reversible obstructive airway disease, and for preventing exercise-induced bronchospasm in the same age group.

 

The development significantly strengthens Cipla’s U.S. respiratory portfolio, adding to its already approved generics for Ventolin HFA and Proventil HFA.

 

Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited, said: "This marks an important milestone for Cipla and reflects our strong scientific and regulatory capabilities in complex inhalation products. Lung health remains at the heart of all our offerings and follows a singular, distilled objective, to build a sustainable and differentiated portfolio for patients globally."

 

The company said the product is supported by its vertically integrated inhalation platform and reflects ongoing investment in advanced U.S. manufacturing capabilities for respiratory therapies.

 

Marc Falkin, Chief Executive Officer, Cipla North America, added: "Strengthening our U.S. respiratory franchise, the product will be manufactured at our newly constructed, dedicated inhalation facility in Fall River, Massachusetts, reinforcing both supply resilience and our domestic manufacturing footprint. With planned volume ramp-up, we expect to drive meaningful difference in the lives of patients."

 

Manufacturing will be carried out at Cipla’s new inhalation facility in Fall River, Massachusetts, underscoring the company’s push to deepen its U.S. production base and improve supply chain resilience for complex respiratory medicines.