The Ritedose Corporation (Ritedose), a company involved in pharmaceutical development, aseptic cGMP manufacturing and 503B outsourcing solutions, began production of a particular form of Albuterol Sulfate that the FDA has listed in short supply in the U.S. It will be available in May.

In March, the U.S. 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.”

The company said that 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.

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.