First U.S. Inhalation Products Manufactured in Tipperary, Marks Major Milestone for Cashel Facility.
Cashel, Co. Tipperary / Bridgewater, New Jersey – Amneal Pharmaceuticals, located on Cahir Road in Cashel, Co. Tipperary, has officially launched two respiratory inhalation products in the United States, following approval by the U.S. Food and Drug Administration in 2025, confirming the accuracy of recent reports and underscoring a significant milestone for both the company and its Irish manufacturing base.
The newly launched products; Albuterol Sulfate Inhalation Aerosol and Beclomethasone Dipropionate HFA Inhalation Aerosol, represent Amneal’s first metered-dose inhalation (MDI) products introduced to the U.S. market, marking the company’s strategic entry into the complex inhalation therapeutics category.
Both medicines are widely prescribed respiratory treatments. Albuterol is used for the treatment and prevention of bronchospasm and exercise-induced bronchospasm in patients aged four years and older, while beclomethasone is a corticosteroid indicated for the maintenance treatment of asthma in patients aged five and above.
Strong Validation of Cashel Manufacturing Operations.
The products are manufactured at Amneal’s dedicated inhalation facility in Cashel, Co. Tipperary; a site that employs approximately 150 people and plays a central role in the company’s global operations. The facility, acquired from Johnson & Johnson in 2015, is specifically designed for complex inhalation product development and production.
The transition to commercial U.S. sales represents a meaningful boost for the local economy, reinforcing the strategic importance of advanced pharmaceutical manufacturing in Ireland.
Addressing Patient Needs and Market Gaps.
Both inhalers utilise a hand-breath actuator device, requiring the patient to depress the canister before inhaling; a format previously discontinued for QVAR®, creating a renewed option for patients and healthcare providers.
According to Amneal, these products address gaps in patient access while increasing competition in a U.S. respiratory market, latter valued at approximately $1.8 billion annually (based on combined category sales data).
Leadership Commentary.
Dr. Srinivas Kone, (Senior Vice President and Chief Scientific Officer – Affordable Medicines), stated: “The launch of these inhalation products marks a significant milestone and reflects our ability to develop and scale complex formulations that address meaningful gaps in patient access. With additional inhalation products in development, we are building a durable presence in this important category.”
Strategic Growth in Complex Medicines.
Headquartered in Bridgewater, New Jersey, Amneal continues to expand its portfolio of complex generics and specialty medicines. The successful U.S. launch of these inhalers highlights the company’s growing capabilities in advanced drug delivery systems and positions it for continued growth in respiratory therapeutics.







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