Ritedose expands portfolio with new FDA-approved antibiotic

A Midlands pharmaceutical manufacturer is adding to its product lineup.

The U.S. Food and Drug Administration has approved The Ritedose Corp.’s manufacturing and distribution of Tobramycin Inhalation Solution to treat patients 6 years and older with infections of Pseudomonas aeruginosa, a common bacterial infection among cystic fibrosis patients, according to a news release.

Tobramycin will be marketed by Ritedose Pharmaceuticals, the generics division of Ritedose (the largest sterile contract development manufacturing organization in the U.S., specializing in aseptic unit-dose medication production using Blow-Fill-Seal technology, the release stated. Ritedose licensed the drug’s Abbreviated New Drug Application from Hikma Pharmaceuticals.

“With the addition of Tobramycin, Ritedose now provides the largest nebulized drug portfolio in the country,” said Ritedose CEO Jody Chastain in the release. “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 in adults and pediatric patients 6 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,” said 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.”