Ritedose Corporation, which says that it is the largest manufacturer of albuterol sulfate inhalation solution in the US, announced that it has begun compounding 5 mg/ml albuterol sulfate inhalation solution ampules through the 503B manufacturing process in response to a shortage, with shipping directly to hospitals expected to begin in May of this year.
The company said, “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.” Ritedose, which already markets 0.021%, 0.042%, and 0.083% albuterol inhalation solution under two existing ANDAs, said that it would submit another ANDA “in other container sizes to meet supply demands.”
According to the FDA Drug Shortage page for the inhalation solution, Akorn has stopped manufacturing the product and has none available, while Nephron’s availability is listed as “on allocation.” While the reason for the Nephron shortage is designated as “other”; the FDA issued a warning letter to the company for cGMP violations in October 2012.
Ritedose CEO Jody Chastain said, “Major shifts in the market’s ability to meet demand has driven our rapid response. 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) ampules that will return stability to the market and ease concerns for healthcare providers and albuterol patients across the country.”
Read the Ritedose press release.
