IntelGenx Obtains Amended Drug Establishment License

IntelGenx (TSXV:IGX; OTCQX:IGXT) announced that after an inspection from Health Canada it has earned an amended Drug Establishment License (DEL) for manufacturing activities.
As quoted in the press release:

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.”

Click here to read the full press release.

Source: www.marketwired.com