Cipla rose 3.48% to Rs 1,277.55 after the company 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 approval covers a product that is the first AB-rated generic therapeutic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline.
The drug is indicated for the treatment or prevention of bronchospasm in adults and children aged four years and above with reversible obstructive airway disease. It is also used to prevent exercise-induced bronchospasm in patients in the same age group.
Cipla said the approval strengthens its respiratory portfolio in the U.S. market. The company already has approved generics for both Ventolin HFA and Proventil HFA.
According to data from IQVIA, the total U.S. market for albuterol inhalers is estimated at around $1.5 billion.
The development is seen as a positive for Ciplas U.S. business, particularly in the respiratory segment, where the company continues to expand its presence with a differentiated portfolio.
Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla, said: 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 and follows a singular, distilled objective, to build a sustainable and differentiated portfolio for patients globally.
Marc Falkin, Chief Executive Officer, Cipla North America, added: Strengthening our U.S. respiratory franchise, the product will be manufactured at our newly constructed, dedicated inhalation facility in Fall River, Massachusetts, reinforcing both supply resilience and our domestic manufacturing footprint. With planned volume ramp-up, we expect to drive meaningful difference in the lives of patients.
Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolios in our home markets of India, South Africa, North America, and key regulated and emerging markets.
The company reported 56.96% decrease in consolidated net profit to Rs 675.80 crore in Q3 FY26 as against Rs 1,570.51 crore in Q3 FY25. Total revenue from operations marginally rose 0.02% YoY to Rs 7,074.48 crore in Q3 FY26.