The Ritedose Corporation (Ritedose) announced that the U.S. Food and Drug Administration (FDA) approved its manufacturing and distribution of Tobramycin Inhalation Solution to treat patients six years and older with infections of Pseudomonas aeruginosa, a common bacterial infection among cystic fibrosis patients.
– Generic Tobramycin Inhalation Solution marks the first cystic fibrosis (CF) product in the Company’s portfolio
– Antibiotic is primarily used for chronic Pseudomonas aeruginosa infections in patients with CF
COLUMBIA, SC, OCT. 30, 2025 — The Ritedose Corporation (Ritedose) announced that the U.S. Food and Drug Administration (FDA) approved its manufacturing and distribution of Tobramycin Inhalation Solution to treat patients six years and older with infections of Pseudomonas aeruginosa, a common bacterial infection among cystic fibrosis patients.
Tobramycin will be marketed by Ritedose Pharmaceuticals, the generics division of Ritedose (the largest sterile contract development manufacturing organization (CDMO) in the U.S., specializing in aseptic unit-dose medication production using Blow-Fill-Seal (BFS) technology). Ritedose licensed the drug’s Abbreviated New Drug Application (ANDA) from Hikma Pharmaceuticals.
“With the addition of Tobramycin, Ritedose now provides the largest nebulized drug portfolio in the country,” said CEO of Ritedose Jody Chastain. “Our recent investments in expanded facilities, cold chain processes and an additional packaging line have given us unparalleled capabilities in sterile manufacturing.”
Tobramycin is an aminoglycoside antibiotic indicated for the treatment of serious bacterial infections, including Pseudomonas aeruginosa (P.aeruginosa), in adults and pediatric patients six years of age and older. The Ritedose formulation is preservative-free and packaged as 300 mg doses in 5 ml ampules, to be administered through a nebulizer device. The medication is now available for purchase.
“Now with Tobramycin in our portfolio, we can provide affordable, safe and reliable medications to patients with serious bacterial infections, expanding access to this critical therapy” continued Chastain. “We’re also proud to strengthen supply chain resilience with the addition of a broad-spectrum antibiotic that is produced here in the United States.”
Tobramycin Inhalation Solution is the third generic drug announced by Ritedose this year. In April, Ritedose Pharmaceuticals received approval to manufacture generic Formoterol Fumarate Inhalation Solution for the maintenance treatment of chronic obstructive pulmonary disease (COPD). In March, Ritedose received approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*, for patients over 12 years of age suffering from acute attacks of bronchospasms or reversible obstructive airway disease. The addition rounded out Ritedose’s complete portfolio of albuterol treatments and addressed a nationwide shortage of the essential drug.
*Potency expressed as albuterol, equivalent to 3 mg of albuterol sulfate.
