Cipla Wins U.S. FDA Nod for First AB-Rated Generic Ventolin Inhaler

Cipla Ltd ( (IN:CIPLA) ) just unveiled an update.

Cipla has secured final U.S. FDA approval for its Abbreviated New Drug Application for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, the first AB-rated generic equivalent to GlaxoSmithKline’s Ventolin HFA. The inhaler, indicated for treating and preventing bronchospasm and exercise-induced bronchospasm in patients aged four and above, is expected to launch in the U.S. in the first half of FY 2026-27.

The approval strengthens Cipla’s U.S. respiratory portfolio and consolidates its leadership in the albuterol inhalation market, which IQVIA values at about $1.5 billion. The product will be manufactured at Cipla’s new dedicated inhalation facility in Fall River, Massachusetts, supporting supply resilience, scaling volumes, and reinforcing the company’s investment in U.S.-based production of complex respiratory therapies.

More about Cipla Ltd

Cipla Limited is an India-headquartered global pharmaceutical company with a strong presence in respiratory therapies, operating through its wholly owned subsidiary Cipla USA Inc. The company focuses on complex inhalation products and is expanding its U.S. footprint, including domestic manufacturing capabilities for advanced respiratory treatments.

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