Cipla receives USFDA approval for its first AB-rated generic of Ventolin HFA (albuterol inhaler), strengthening its U.S. respiratory portfolio and manufacturing footprint.
Written By: Pharmacally Medical News Desk
Cipla Limited and its wholly owned subsidiary Cipla USA Inc. have received final approval from the United States Food and Drug Administration (USFDA) for their Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation.
The approved product is the first AB-rated generic therapeutic equivalent of Ventolin® HFA, a widely used rescue inhaler marketed by GlaxoSmithKline. An AB rating indicates that the generic is therapeutically equivalent to the reference listed drug and can be substituted at the pharmacy level.
Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and pediatric patients aged four years and older with reversible obstructive airway disease. It is also approved for preventing exercise-induced bronchospasm in the same age group.
According to IQVIA estimates, the total U.S. albuterol market is valued at approximately $1.5 billion, underscoring the commercial relevance of this approval.
The addition of this product strengthens Cipla’s respiratory portfolio in the United States, where the company now offers approved generic versions of both Ventolin® HFA and Proventil® HFA. These inhalers are commonly prescribed for conditions such as asthma and chronic obstructive pulmonary disease (COPD).
In a statement, Achin Gupta, Managing Director and Global CEO of Cipla Limited, highlighted that the approval reflects the company’s capabilities in developing and securing regulatory clearance for complex inhalation therapies. He emphasized that respiratory care remains a central focus area, with efforts directed toward building a sustainable and differentiated global portfolio.
Marc Falkin, Chief Executive Officer of Cipla North America, noted that the product will be manufactured at the company’s newly established inhalation facility in Fall River, Massachusetts. He indicated that domestic manufacturing is expected to support supply resilience and enable planned volume expansion to meet patient demand.
The product is supported by Cipla’s vertically integrated inhalation platform, reflecting ongoing investment in U.S.-based manufacturing capabilities for complex respiratory therapies.
Reference
Cipla Receives U.S. FDA Approval for First AB-Rated Generic of Ventolin® HFA | Cipla
