The United States Food and Drug Administration (USFDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. This landmark approval declares Cipla’s product as the first AB-rated generic therapeutic equivalent to GlaxoSmithKline’s Ventolin® HFA.
Albuterol Sulfate Inhalation Aerosol is a vital treatment indicated for the prevention and treatment of bronchospasm in adults and pediatric patients aged four years and older. It is also used to prevent exercise-induced bronchospasm in the same age group. With total U.S. albuterol market valued at approximately $1.5 billion, this approval reinforces Cipla’s leadership in this category. Cipla now holds approved generics for both major brands: Ventolin® HFA and Proventil® HFA.The launch is supported by Cipla’s significant investment in domestic, high-tech manufacturing. The product will be produced at a newly constructed, dedicated inhalation facility in Fall River, Massachusetts. The product utilizes Cipla’s vertically integrated inhalation platform, ensuring quality control from development to delivery.
Achin Gupta, Managing Director & Global CEO, Cipla Limited, stated, “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 as we build a sustainable and differentiated portfolio for patients globally.”
Cipla is transitioning toward a more resilient, domestic manufacturing model. This reduces reliance on international logistics and ensures a consistent supply of essential lung health medicines for the U.S. healthcare system and allows for seamless pharmacy substitution. Looking forward, this approval is not merely a single product launch but a strategic blueprint for Cipla’s future, blending scientific innovation with a commitment to sustainable, global lung health. The planned volume ramp-up is expected to drive a meaningful difference in patient lives by lowering the cost barriers to critical asthma and COPD treatments.
By Pragna Biswas
