COLUMBIA, SC May 1, 2025 — Ritedose Pharmaceuticals, a division of The Ritedose Corporation (Ritedose), was granted approval by the US Food and Drug Administration (FDA) to manufacture and market generic formoterol fumarate inhalation solution (20 mcg/2 mL), a treatment for chronic obstructive pulmonary disease (COPD) and other respiratory ailments. The company expects to begin shipping the drug, mainly to retail pharmacies and hospitals, by the beginning of summer 2025.  

“Expanding our generics portfolio is one more way we’re working to meet the real, ongoing needs of patients and our partners,” said Jody Chastain, President and CEO of Ritedose. “It’s estimated that between 13 and 15 million people have a clinical need for this drug. With a strong pipeline in development and several product launches on the horizon, we’re committed to being a dependable generics manufacturer.” 

Ritedose purchased the abbreviated new drug application (ANDA) from another manufacturer last year and submitted its filing to the FDA to transfer manufacturing to Ritedose. The April 2025 FDA approval of that filing allows Ritedose to provide much-needed treatments for these common respiratory disorders.  

About The Ritedose Corporation   

Ritedose is the largest sterile contract development manufacturing organization (CDMO) in the US specializing in sterile Blow Fill Seal (BFS) technology that ensures sterile, consistent, and safe unit dose delivery. The company’s process guides the development of molecules from clinical trials to commercialization of branded and generic inhalation and ophthalmic medications. With a focus on quality, innovation, and customer satisfaction, Ritedose partners with leading pharmaceutical companies to deliver safe, effective, and reliable medications that improve patient outcomes. Ritedose: Passion and Precision with a Purpose. For more information visit Ritedose.com