Genixus, a pharmaceutical company focused on transforming acute and critical care medicines, today announced that it has received both federal registration and state licensing to begin commercial production of its new KinetiX™ RTA Platform brand of pre-filled syringes. The company recently received federal 503B and Repackaging registration from the U.S. Food & Drug Administration under the Human Drug Outsourcing Facilities of the FD&C Act and Current Good Manufacturing Practices (CGMP), in addition to North Carolina Drug Manufacturing and Repackaging licensure.
The federal registration and state licensing at its state-of-the-art facility in Kannapolis, NC will enable Genixus to initiate commercialization of the KinetiX™ RTA Platform of pre-filled syringe medications beginning later this year. Driven by quality, simplicity, and transparency, the KinetiX™ RTA Platform is designed to deliver clinical tools that seamlessly integrate into the acute and critical care setting.
"With advanced manufacturing leveraging our experience in biologics and innovative delivery systems, the KinetiX™RTA Platform will feature products that apply critical thinking to every stage of the care journey, ensuring our products integrate seamlessly with healthcare processes and workflows," said Kendall Foster, Founder & Chief Executive Officer of Genixus. "Our passion is to deliver solutions that drive simplicity and support the heroes on the frontline of healthcare, to help eliminate distraction and allow them to focus on what they do best: drive optimal outcomes for patients."
The federal registration and state licensure builds on the momentum from previous investments in the Kannapolis manufacturing facility, including new cleanrooms, support areas, and testing labs.
"The recent federal registration and state licensure allows acceleration of our efforts to bring clinical tools designed to simplify operations and execution in the acute and critical care space," noted Seth Coombs, Co-Founder and Chief Commercial Officer of Genixus. "We worked with clinical staff nationwide to apply the learnings of real-world application to our KinetiX™RTA Platform. We are excited to provide these products to hospitals and clinics and continue to learn, so we can create the optimal desired solution for subsequent submission to the FDA."