Cipla Receives U.S. FDA Approval for First AB-Rated Generic of Ventolin® HFA

Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla") and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as "Cipla"), today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation from the United States Food and Drug Administration (USFDA). It is the first AB-rated generic therapeutic equivalent of Ventolin® HFA, marketed by GlaxoSmithKline.

Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged four years and older with reversible obstructive airway disease, as well as for the prevention of exercise-induced bronchospasm in patients aged four years and older.

According to IQVIA*, the total U.S. albuterol market is valued at approximately $1.5 billion.

This approval enhances Cipla's U.S. respiratory portfolio and reinforces its leadership in the albuterol inhalation category, with approved generics for both Ventolin® HFA and Proventil® HFA.

Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited, 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."

The product is backed by Cipla's vertically integrated inhalation platform, reflecting the company's continued investment in U.S.-based manufacturing for complex respiratory therapies.

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.

Shares of Cipla Limited was last trading in BSE at Rs. 1305.85 as compared to the previous close of Rs. 1235.00. The total number of shares traded during the day was 323979 in over 11383 trades.

The stock hit an intraday high of Rs. 1308.60 and intraday low of 1228.80. The net turnover during the day was Rs. 415806757.00.

Source : Equity Bulls

Keywords

Cipla INE059A01026 CIPLAUSAInc Pharmaceuticals ANDA FinalApproval USFDA