Cipla Limited and its wholly owned subsidiary Cipla USA Inc. received final approval from the United States Food and Drug Administration (USFDA) for their Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation).

The product is the first AB-rated generic therapeutic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline. It is indicated for the treatment or prevention of bronchospasm in adults and children aged four years and above with reversible obstructive airway disease, and for preventing exercise-induced bronchospasm in the same age group.

According to market estimates from IQVIA, the U.S. albuterol market is valued at around $1.5 billion.

The approval strengthens Cipla’s respiratory portfolio in the U.S., where it now has approved generics for both Ventolin HFA and Proventil HFA. The product is supported by the company’s vertically integrated inhalation platform, reflecting its focus on complex respiratory therapies.

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.”  

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 a meaningful difference in the lives of patients.”