IntelGenx's site has secured an amended Drug Establishment License (DEL) for manufacturing activities after a Good Manufacturing Practices (GMP) inspection carried out by Health Canada.
The Company successfully achieved a GMP compliant rating, allowing the site to conduct licensable commercial manufacturing and packaging activities of finished dosage forms.
The Health Canada GMP audit included a thorough review of the existing quality management systems, supplier management, controls of raw materials, documentation, equipment, processes and engineering.
No critical deficiencies preventing a GMP Compliant rating were identified. IntelGenx intends to respond with a plan to address Health Canada's initial inspection observations within the next 30 days.
"Health Canada's amended DEL represents a major achievement for our Company and, as it was the last milestone before we could initiate manufacturing at our new state-of-the-art facility," said Dr. Horst G. Zerbe, President and CEO of IntelGenx.
"It also marks a key step towards the commercialization of our products. For example, the amended DEL will support applications to transfer the manufacturing of RIZAPORT®, our proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines, from Europe to IntelGenx' site."
Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.
IntelGenx' highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services.
IntelGenx' state-of-the-art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to its clients.