Cipla receives U.S. FDA approval for first AB Rated Generic of Ventolin® HFA
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Cipla's wholly owned subsidiary Cipla USA Inc. has received final USFDA approval for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, the first AB-rated generic therapeutic equivalent of Ventolin® HFA (GlaxoSmithKline's product). The drug treats or prevents bronchospasm in adults and children aged 4+ with reversible obstructive airway disease, and prevents exercise-induced bronchospasm. According to IQVIA, the total U.S. albuterol market is valued at approximately $1.5 billion. The product will be launched in H1 of FY 2026-27 and manufactured at Cipla's newly constructed inhalation facility in Fall River, Massachusetts. This approval strengthens Cipla's U.S. respiratory portfolio, with approved generics for both Ventolin® HFA and Proventil® HFA.
Positive for shareholders as Cipla enters a $1.5 billion market with a first-to-market generic, enhancing its U.S. respiratory franchise and vertically integrated inhalation platform.