Cipla’s wholly owned subsidiary -- Cipla USA Inc (Cipla) has received final approval from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 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 around $1.5 billion. 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.

Cipla is in the business of manufacturing, developing, and marketing wide range of branded and generic formulations and Active Pharmaceutical Ingredients (APIs).