Ritedose Secures FDA Approval To Manufacture Generic Tobramycin Inhalation Solution, Now Holds The Largest Nebulized Drug Portfolio In The U.S.

The Ritedose Corporation (Ritedose) has announced that the U.S. Food and Drug Administration (FDA) has approved its manufacturing and distribution of Tobramycin Inhalation Solution. This medication is indicated for the treatment of infections caused by Pseudomonas aeruginosa in patients aged six years and older—a common and serious bacterial infection among individuals with cystic fibrosis.

Tobramycin Inhalation Solution will be marketed by Ritedose Pharmaceuticals, the generics division of Ritedose, which is recognized as the largest sterile contract development and manufacturing organization (CDMO) in the United States. The company is widely known for its specialization in aseptic unit-dose medication production using advanced Blow-Fill-Seal (BFS) technology. Ritedose licensed the Abbreviated New Drug Application (ANDA) for Tobramycin from Hikma Pharmaceuticals, further expanding its growing generics portfolio.

Jody Chastain, Chief Executive Officer of Ritedose, stated, “With the addition of Tobramycin, Ritedose now offers the largest nebulized drug portfolio in the country. Our ongoing investments in facility expansion, enhanced cold chain capabilities, and additional packaging lines have allowed us to further strengthen our leadership in sterile manufacturing.”

Tobramycin is an aminoglycoside antibiotic designed to treat serious bacterial infections, particularly those caused by Pseudomonas aeruginosa. The newly approved Ritedose formulation is preservative-free and comes in 300 mg doses contained in 5 ml ampules. It is intended for administration via a nebulizer, providing an effective inhalation therapy for patients managing chronic respiratory infections. The product is now available for purchase in the United States.

Commenting on the launch, Chastain added, “By including Tobramycin in our portfolio, we are expanding access to affordable, safe, and reliable medications for patients with severe bacterial infections. This addition also reinforces our commitment to strengthening the domestic pharmaceutical supply chain through the production of high-quality, broad-spectrum antibiotics right here in the U.S.”

The FDA approval of Tobramycin marks the third generic drug introduction by Ritedose this year. Earlier in 2025, the company received regulatory approval for two other key inhalation therapies. In April, Ritedose Pharmaceuticals gained approval for generic Formoterol Fumarate Inhalation Solution, used in the maintenance treatment of chronic obstructive pulmonary disease (COPD). In March, it received approval for Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL), for patients over 12 years old experiencing acute bronchospasms or reversible obstructive airway disease.

The approval of these products has enabled Ritedose to establish a comprehensive portfolio of essential inhalation medications while helping to mitigate nationwide shortages of critical respiratory treatments. With the addition of Tobramycin, Ritedose continues to strengthen its role as a leading U.S.-based manufacturer focused on quality, reliability, and innovation in sterile drug production.