Summit Biosciences Announces Successful FDA Preapproval Inspection for Manufacturing of Nasal Spray Drug Product
Lexington, KY, March 27, 2014 - Summit Biosciences Inc., a specialty pharmaceutical company, is pleased to announce that the manufacturing facility in Lexington, Kentucky has successfully passed its first preapproval inspection by the Food and Drug Administration (FDA).
The inspection for a new nasal spray drug product, which concluded the week of February 24th, was conducted by two divisions of the FDA (drug and medical device). The site was found to be in compliance with current Good Manufacturing Practices (cGMPs) and received no 483 observations.
"Our team's expertise, drive and focus on quality have enabled us to secure top tier clients and partners that have put their trust in us to manufacture their products. This trust and our performance have now been validated by a successful FDA inspection; We are extremely pleased with the results of this inspection and believe it is a direct reflection of our high caliber team and their commitment to quality in all areas of our operations," said Greg Plucinski, Chief Operating Officer of Summit Biosciences.
About Summit Biosciences
Summit Biosciences Inc. is a specialty pharmaceutical company focused on developing, manufacturing and commercializing generic and innovative nasal spray drug products. Summit's headquarters and manufacturing facility is located on the University of Kentucky's (UK) Coldstream Research Campus in Lexington, KY. In addition to developing an internal pipeline of products, the company provides a broad spectrum of services and expertise in nasal spray product development, manufacturing and analytical testing to pharmaceutical organizations with the goal of commercializing products for both the generic and branded markets. Along with several generic products, the internal pipeline includes a delta-9 tetrahydrocannabinol (THC or medical marijuana) nasal spray using intellectual property licensed from UK. Since inception in late 2009, the company has created over 20 high-tech jobs in the Commonwealth of KY, which has exceeded the hiring commitment made to secure a forgivable loan and tax incentives from the state.