Cipla Receives US FDA Approval for First AB-Rated Generic of Ventolin® HFA
Cipla Limited announced that its wholly owned subsidiary, Cipla USA Inc., received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA). The approval pertains to Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, marking it as the first AB-rated generic therapeutic equivalent of Ventolin® HFA, a product marketed by GlaxoSmithKline.Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm. It is suitable for adult and pediatric patients aged four years and older with reversible obstructive airway disease, and also for the prevention of exercise-induced bronchospasm in patients aged four years and older.
This approval significantly strengthens Cipla’s U.S. respiratory portfolio and reinforces the company’s leadership within the albuterol inhalation category, as Cipla already holds approved generics for both Ventolin® HFA and Proventil® HFA.
The product is expected to launch in the United States of America in the first half of Fiscal Year 2026-27.
Market and Operational Significance
The successful USFDA approval marks a major milestone for Cipla, reflecting its scientific and regulatory capabilities in complex inhalation products. Cipla's integrated inhalation platform supports the launch, which will be manufactured at the company’s newly constructed, dedicated inhalation facility in Fall River, Massachusetts.According to IQVIA, the total U.S. albuterol market is currently valued at approximately $1.5 billion.
| Metric | Detail | Value |
|---|---|---|
| Product Name | Albuterol Sulfate Inhalation Aerosol | N/A |
| Drug Strength | 90 mcg per actuation | N/A |
| Market Status | First AB-rated generic equivalent of Ventolin® HFA | N/A |
| Market Value (U.S.) | Total albuterol market | $1.5 billion |
| Expected Launch | USA | H1 of FY 2026-27 |
Cipla management highlighted that the company's continuous focus on lung health and the commitment to building a differentiated portfolio are central to its global objectives. The move reinforces Cipla's supply resilience and domestic manufacturing footprint in the highly specialized respiratory therapy sector.
CIPLA Stock Price Movement
As of 9:50 AM, Cipla Limited shares are rallying to ₹1278, jumping 3.37% in live trading. The strong upward momentum is supported by high liquidity, with 680,534 shares trading hands in the market so far today.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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