Cipla Limited, along with its subsidiary Cipla USA Inc., has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol (90 mcg).
The approval marks the launch of the first AB-rated generic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline. The inhaler is used to treat and prevent bronchospasm in patients aged four years and above, including those with reversible airway diseases and exercise-induced bronchospasm.
With the U.S. albuterol market estimated at around $1.5 billion, this approval strengthens Cipla’s respiratory portfolio and solidifies its presence in the inhalation segment, where it now offers generics for both Ventolin HFA and Proventil HFA.
Managing Director and Global CEO Achin Gupta said the milestone highlights the company’s strong capabilities in complex inhalation therapies and its commitment to expanding a differentiated global respiratory portfolio.
The product will be manufactured at Cipla’s dedicated inhalation facility in Fall River, Massachusetts, supporting its strategy to enhance supply resilience and expand its U.S. manufacturing footprint.