IntelGenx (OTCQX:IGXT; TSXV:IGX) announced that its plant, following a Good Manufacturing Practices (GMP) inspection performed by Health Canada, has obtained an amended Drug Establishment License (DEL) for manufacturing activities.
A GMP compliant rating allows 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.
"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," Dr. Horst Zerbe, president and CEO of IntelGenx, said in a statement. "It also marks a key step towards the commercialization of our products.”
For example, he said the amended DEL would support applications to transfer the manufacturing of Rizaport, an oral thin-film formulation of rizatriptan for the treatment of acute migraines, from Europe to the IntelGenx site.