COLUMBIA, S.C. (April 25, 2023) – The Ritedose Corporation (Ritedose), an industry leader in pharmaceutical development, aseptic cGMP manufacturing and 503B outsourcing solutions, has begun production of a particular form of Albuterol Sulfate that the FDA has listed in short supply in the United States. It will be available in May.
Ritedose is the nation’s largest Albuterol Sulfate inhalation solution manufacturer.
In March, the U.S. Food and Drug Administration (FDA) announced a drastic downturn in the nation’s supply of Albuterol Sulfate (0.5% Inhalation Solution). The medication, a breathing treatment for asthma and certain types of chronic obstructive pulmonary disease (COPD), is considered an “essential medication” by the FDA, with the 0.5% Inhalation Solution having an annual demand of nearly 20 million doses per year. Until recently, the 5mg/ml concentration was supplied to the market by Akorn, Inc and Nephron Pharmaceuticals.
“Major shifts in the market’s ability to meet demand has driven our rapid response,” said Jody Chastain, CEO of The Ritedose Corporation. “Our manufacturing flexibility is ideally suited to step into this role. The Ritedose Corporation’s 503B Outsourcing Facility will be distributing Albuterol 0.5% [5 mg/mL] 75 mg/15 mL in Blow Fill Seal (BFS) ampoules that will return stability to the market and ease concerns for healthcare providers and Albuterol patients across the country.”
While products produced through the 503B manufacturing process are prohibited from being sold and distributed via wholesalers, Ritedose will compound the 5mg/ml concentration of Albuterol Sulfate with distribution directly to hospitals and clinicians under the current drug shortage. Working with several of the large hospital systems in the nation allowed Ritedose to accelerate development from a typical six-month timeframe down to a record timeline of only four months, as the need for quality supply outpaced the desire for a longer shelf life.
“Our team at Ritedose knows what ‘rolling up our sleeves’ looks like, as we were in the trenches helping with the Covid crisis and will do the same with this shortage,” continued Chastain. “We are all about patient safety and reliability—the U.S. can count on us to step-up and solve the drug shortage gap of Albuterol Sulfate.”
For long-term supply chain continuity, Ritedose will be submitting an additional Abbreviated New Drug Application (ANDA) in other container sizes to meet supply demands.
Founded in 1995 in Columbia, South Carolina, The Ritedose Corporation is an industry leader in the aseptic manufacturing and liquid packaging of drug products and utilizes proven Blow-Fill-Seal (BFS) equipment and processes to ensure efficient, consistent and safe dosage delivery. The company’s 27-year track record includes delivery of more than 10 billion doses since 2012 without interruption, and its current capacity is 2 billion units annually. To learn more about all Ritedose products, view the product catalog or email us at sales503B@ritedose.com with order information.