Cipla Share Price Gains Over 4%; Secures US FDA Approval for Generic Version of Ventolin HFA with AB Rating

Cipla Limited, along with its subsidiary Cipla USA Inc., has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation.  

This marks the first AB-rated generic equivalent of Ventolin HFA, originally marketed by GlaxoSmithKline. 

Cipla's Strategic Move in the US Respiratory Market 

The approval of Cipla's Albuterol Sulfate Inhalation Aerosol is a significant development in the US respiratory market.  

The product is indicated for treating or preventing bronchospasm in patients aged 4 years and older with reversible obstructive airway disease, as well as for preventing exercise-induced bronchospasm.  

According to IQVIA, the US albuterol market is valued at approximately $1.5 billion. 

This approval strengthens Cipla’s position in the albuterol inhalation category, adding to its existing generics for Ventolin HFA and Proventil HFA. The product is expected to launch in the first half of FY 2026-27 in the US. 

Manufacturing and Market Impact 

Cipla’s Albuterol Sulfate Inhalation Aerosol will be manufactured at its newly constructed inhalation facility in Fall River, Massachusetts.  

This facility underscores Cipla's investment in US-based manufacturing for complex respiratory therapies, enhancing supply resilience and domestic manufacturing capabilities. 

Marc Falkin, CEO of Cipla North America, highlighted the significance of this development in strengthening Cipla’s US respiratory franchise. The planned volume ramp-up is expected to make a meaningful difference in patients' lives. 

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About Cipla Limited 

Established in 1935, Cipla is a global pharmaceutical company focused on agile growth, complex generics, and expanding its portfolio in key markets like India, South Africa, and North America.  

The company operates 46 manufacturing sites worldwide, producing over 1,500 products across 80+ markets. 

Cipla Share Price Performance 

As of April 23, 2026, at 12:05 PM, Cipla share price on NSE was trading at ₹1,286.50 up by 4.06% from the previous closing price. 

Conclusion 

Cipla's US FDA approval for its AB-rated generic Ventolin HFA highlights its capabilities in complex inhalation products and reinforces its leadership in the respiratory segment. This strategic move is set to enhance Cipla's presence in the US market. 

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