Cipla Secures FDA Approval for Generic Ventolin HFA Inhaler

Cipla Limited and its subsidiary, Cipla USA Inc., have received final approval from the U.S. Food and Drug Administration (FDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation. The product is the first AB-rated generic therapeutic equivalent of Ventolin® HFA, strengthening Cipla's respiratory portfolio in the United States.

A Significant Regulatory Milestone

The approval was granted for Cipla's Abbreviated New Drug Application (ANDA), allowing the company to offer a generic alternative to Ventolin HFA. An AB rating indicates that the generic product has been evaluated as therapeutically equivalent to its reference drug, supporting pharmacy-level substitution where permitted.

Product at a Glance

① Product: Albuterol Sulfate Inhalation Aerosol

② Strength: 90 mcg per actuation

③ Regulatory Approval: Final U.S. FDA approval

④ Reference Product: Ventolin® HFA

⑤ Status: First AB-rated generic therapeutic equivalent

⑥ Target Area: Respiratory care

Supporting Bronchospasm Treatment

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 indicated for the prevention of exercise-induced bronchospasm in eligible patients.

◆ Treatment or prevention of bronchospasm

◆ Use in adults and pediatric patients aged four years and above

◆ Prevention of exercise-induced bronchospasm

Expanding Cipla's U.S. Respiratory Portfolio

The approval adds to Cipla's respiratory product portfolio in the United States. The company already has approved generic products in the albuterol inhalation category, and this latest approval further expands its position in a significant respiratory market.

→ Strengthens Cipla's U.S. respiratory business

→ Adds a first AB-rated generic equivalent of Ventolin HFA

→ Supports Cipla's portfolio of complex inhalation products

→ Addresses the approximately $1.5 billion U.S. albuterol market, according to IQVIA data cited by Cipla

U.S.-Based Manufacturing Support

The product is planned to be manufactured at Cipla's dedicated inhalation facility in Fall River, Massachusetts. The facility is intended to support the company's U.S. manufacturing capabilities and help strengthen supply resilience for complex respiratory therapies.

What This Approval Represents

The FDA approval marks an important development for Cipla's respiratory business and its capabilities in complex inhalation products. With an AB-rated generic version of Ventolin HFA, the company is expanding its product offering in the U.S. market while building on its investment in inhalation technology and domestic manufacturing.