Cipla Limited and its wholly owned subsidiary Cipla USA Inc have received final approval from the US Food and Drug Administration (USFDA) for their Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. The product is the first AB-rated generic equivalent of Ventolin® HFA, originally marketed by GlaxoSmithKline.
The inhalation aerosol is indicated for the treatment and prevention of bronchospasm in adults and children aged four years and above suffering from reversible obstructive airway diseases. It is also prescribed for the prevention of exercise-induced bronchospasm in patients within the same age group. The approval provides patients in the United States with access to a clinically equivalent and more affordable treatment option.
According to industry estimates, the U.S. market for albuterol inhalation therapies is valued at approximately $1.5 billion, underscoring the significance of this development. With this approval, Cipla strengthens its respiratory portfolio in the U.S. and reinforces its position in the albuterol segment, where it now holds approved generics for both Ventolin® HFA and Proventil® HFA.
Company leadership highlighted that the approval reflects Cipla’s capabilities in developing complex inhalation products, supported by strong scientific expertise and regulatory execution. The company continues to prioritize respiratory care as a key focus area, with a commitment to building a differentiated and sustainable global portfolio.
The product will be manufactured at Cipla’s dedicated inhalation facility in Fall River, Massachusetts, representing a significant investment in U.S.-based manufacturing. The facility is designed to support high-quality production and ensure supply reliability, with plans for a phased scale-up to meet market demand.
Cipla’s vertically integrated inhalation platform has played a critical role in enabling this development, combining formulation expertise, device engineering, and manufacturing capabilities. The company expects the launch to improve patient access and contribute meaningfully to respiratory healthcare outcomes.
Founded in 1935, Cipla has grown into a global pharmaceutical company with a strong presence across India, South Africa, North America, and other regulated and emerging markets. With 46 manufacturing facilities worldwide, the company produces a wide range of dosage forms and serves more than 80 markets.
Driven by its purpose of “Caring for Life,” Cipla has a long-standing legacy of improving access to essential medicines. Its continued focus on innovation, affordability, and patient-centric solutions positions it as a key contributor to global healthcare advancement.
