Cipla Gets USFDA Approval for Albuterol Inhaler, Expands US Respiratory Portfolio
Mumbai: Cipla Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, the first AB-rated generic equivalent of Ventolin HFA-through its wholly owned subsidiary Cipla USA Inc., with the product expected to be launched in the US market in the first half of FY 2026-27.
The approved product is therapeutically equivalent to Ventolin HFA, originally marketed by GlaxoSmithKline, and is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged four years and above with reversible obstructive airway disease. It is also indicated for the prevention of exercise-induced bronchospasm in the same age group.
According to IQVIA data for MAT February 2026, the US market for albuterol inhalation products is estimated at approximately $1.5 billion, highlighting a significant commercial opportunity for the company.
This approval strengthens Cipla’s respiratory portfolio in the United States and reinforces its leadership in the albuterol inhalation segment, where it now has approved generics for both Ventolin HFA and Proventil HFA.
Commenting on the development, Achin Gupta, Managing Director and Global CEO of Cipla Limited, stated that the approval represents a key milestone reflecting the company’s strong scientific and regulatory capabilities in complex inhalation therapies. He added that lung health continues to remain a core focus area for the company as it aims to build 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 highlighted that this will strengthen domestic manufacturing capabilities, improve supply resilience, and support planned volume ramp-up to enhance patient access.
The product is supported by Cipla’s vertically integrated inhalation platform, underscoring its continued investment in advanced manufacturing infrastructure for respiratory therapies in the United States.
Cipla Limited, established in 1935, is a global pharmaceutical company with a presence in over 80 markets and a portfolio spanning more than 1,500 products across 50+ dosage forms. The company operates 46 manufacturing sites worldwide and has strong capabilities in therapeutic areas including respiratory, antiretroviral, urology, cardiology, anti-infectives, and CNS.
Cipla is ranked among the top pharmaceutical companies globally, including being the third largest in India, second largest in South Africa’s prescription market, and third largest by prescription in the US generics inhalation segment. Over the decades, the company has played a significant role in improving access to affordable healthcare, notably through its landmark initiative in 2001 to provide triple antiretroviral therapy for HIV/AIDS at under one dollar per day in Africa. The approval marks a significant step in Cipla’s strategy to expand its presence in complex generics and respiratory therapies in regulated markets.
