Cipla Limited on April 23 announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, a generic equivalent of Ventolin HFA.
The approval marks a key milestone for the company as it becomes the first AB-rated generic therapeutic equivalent of Ventolin HFA, a widely used inhaler marketed by GlaxoSmithKline. The product is indicated for the treatment or prevention of bronchospasm in adult and paediatric patients aged four years and above suffering from reversible obstructive airway disease. It is also used for preventing exercise-induced bronchospasm.
According to IQVIA data, the total US market for albuterol inhalers is estimated at approximately $1.5 billion, indicating a significant opportunity for Cipla in the respiratory segment.
The development strengthens Cipla’s presence in the US respiratory portfolio, where it already has approved generics for both Ventolin HFA and Proventil HFA. The company said the product will be manufactured at its dedicated inhalation facility in Fall River, Massachusetts, further enhancing supply chain resilience and domestic manufacturing capabilities in the US.
Achin Gupta, Managing Director and Global CEO of Cipla Limited, said the approval reflects the company’s strong scientific and regulatory capabilities in complex inhalation products. He added that the development aligns with Cipla’s focus on building a sustainable and differentiated respiratory portfolio globally.
Marc Falkin, Chief Executive Officer of Cipla North America, said the launch will strengthen the company’s respiratory franchise in the US and help deliver improved access to patients through high-quality inhalation therapies.
The approval is expected to support Cipla’s growth in the US generics market, particularly in the high-value respiratory segment, while reinforcing its position in complex generics and specialty pharmaceuticals.