Cipla Limited and its wholly owned subsidiary Cipla USA Inc., announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation from the United States Food and Drug Administration (USFDA). It is the first AB–rated generic therapeutic equivalent of Ventolin® HFA, marketed by GlaxoSmithKline.
Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged four years and older with reversible obstructive airway disease, as well as for the prevention of exercise–induced bronchospasm in patients aged four years and older.
According to IQVIA*, the total U.S. albuterol market is valued at approximately 1.5 billion USD.
This approval enhances Cipla's U.S. respiratory portfolio and reinforces its leadership in the albuterol inhalation category, with approved generics for both 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 product is backed by Cipla's vertically integrated inhalation platform, reflecting the company's continued investment in U.S.-based manufacturing for complex 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."
