Ritedose Corporation announced that it licensed an ANDA for tobramycin inhalation solution from Hikma and that the FDA has approved the company to manufacture and distribute the product. The company noted that tobramycin, which is approved for the treatment of P. aeruginosa lung infections in cystic fibrosis patients, is its first product for CF. The inhalation solution, which is packaged in 5 ml ampules, is already available through Ritedose Pharmaceuticals.
The company also pointed out that tobramycin is the third generic inhalation solution that it has launched in 2025. In May, Ritedose announced that the FDA had approved the transfer of an ANDA for formoterol fumarate inhalation solution and that the agency had approved an ANDA for the company’s generic albuterol sulfate inhalation solution, 0.5%. Ritedose Pharmaceuticals also sells a number of other inhalation solutions, including ipatropium bromide, arformoterol tartrate, and cromolyn sodium.
Ritedose has been expanding its capacity to produce inhalation solutions, including the addition of blow-fill-seal (BFS) capacity and an expansion of its cGMP laboratories. In addition to producing its own sterile products, the company offers contract manufacturing for nebulized products, including Verona Pharma’s Ohtuvayre ensifentrine.
Ritedose CEO Jody Chastain commented, “With the addition of tobramycin, Ritedose now provides the largest nebulized drug portfolio in the country. Our recent investments in expanded facilities, cold chain processes and an additional packaging line have given us unparalleled capabilities in sterile manufacturing. 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. 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.”
Read the Ritedose Corporation press release
