Manufacturing
ITI’s nasal spray manufacturing facility is dedicated to the formulation, filling, assembly and packaging of aseptically filled, sterile nasal spray drug products for clinical studies, initial FDA registration and commercialization. We believe that this highly automated, custom-designed plant is the only commercial-scale facility of its kind in the United States.
The manufacturing facility has been designed to fully comply with the FDA’s current Good Manufacturing Practices (cGMPs) and equivalent European Union standards. Located on the University of Kentucky’s Coldstream Research Campus, the plant consists of manufacturing, laboratory and office space.
The facility has an annual capacity of approximately 22 million unit dose nasal sprayers for commercial distribution. Future facility expansion will new add capacity for filling, assembling, packaging, and warehousing, as well as new lines for bi-dose and multi-dose nasal products.
No preservatives,
greater comfort
ITI nasal spray products are preservative-free and thus less likely than similar products now on the market to irritate the nasal membranes. MORE
