Ritedose Pharmaceuticals Receives FDA Approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*--Addressing Nationwide Shortage of the Essential Drug

Ritedose has the largest portfolio of nebulizer products, with new dosage completing the company's portfolio of albuterol treatments

COLUMBIA, S.C., May 20, 2025 /PRNewswire/ -- Ritedose Pharmaceuticals, a division of The Ritedose Corporation (Ritedose), the largest sterile contract development manufacturing organization (CDMO) in the US specializing in aseptic unit-dose medication production using Blow-Fill-Seal (BFS) technology, received US Food and Drug Administration (FDA) approval for manufacturing and distributing generic Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*

"Driven by the needs of escalating health demands in the U.S., Ritedose is strategically expanding its support for critical respiratory therapies. For the more than 26 million patients suffering from bronchospasms associated with reversible obstructive airway diseases like asthma, this approval brings much-needed access to a critical therapy," said Jody Chastain, CEO of Ritedose. "Amid a national shortage of this essential drug, we're proud to step-up and help bridge the gap with a full range of albuterol dosages. Patients are at the center of everything we do here at Ritedose."

To date, Ritedose has the largest portfolio of nebulizer products available—having delivered more than 4.5 billion doses over the company's lifetime. The albuterol doses will be manufactured in the company's expanded, state-of-the-art facilities using its advanced BFS technology, which ensures an automated, safe and reliable process. Each single dose will be preservative-free, as well as individually wrapped and barcoded.

The 2.5 mg/0.5 ml dosage rounds out Ritedose's complete portfolio of albuterol treatments, as the company currently has approved applications for (2.5 mg/3 mL (0.083%), 1.25 mg/3 mL and 0.63 mg/3 mL) strength products as well. This new dosage also helps address a nationwide shortage of the essential drug, which has been reported by the FDA since October 2022. Ritedose estimates that the dosage will be available starting in the second quarter of 2025. 

Chastain continued, "Our recent expansion and new packaging line ensures we have the capacity to deliver this medication consistently, efficiently, and safely. This milestone reflects the dedication of our hard-working employees, whose commitment is to meet a real and urgent need for patients both in their communities and in communities across the country."

The drug is primarily used to provide relief of bronchospasms in patients older than 12 years with reversible obstructive airway disease (asthma), and for treating acute attacks of bronchospasm. In the United States alone, more than 26 million people are known to have asthma, and about 7 million of them are children.

This announcement comes on the heels of Ritedose recently announcing the addition of its seventh Syntegon packaging line to expand single vial packaging capabilities.

*Potency expressed as albuterol, equivalent to 3 mg of albuterol sulfate

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 

Media Contact:

Alex Keown
Inspire Agency on Behalf of Ritedose
630.346.5141
[email protected]

SOURCE Ritedose