IntelGenx Site Obtains GMP Compliant Rating From Health Canada for Manufacturing and Packaging Activities
SAINT-LAURENT, QUEBEC–(Marketwired – Dec. 18, 2017) – IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”) is pleased to announce that, following a Good Manufacturing Practices (“GMP”) inspection performed by Health Canada, its site has obtained an amended Drug Establishment License (“DEL”) for manufacturing activities.
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.”
About IntelGenx:
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. More information about the company can be found at www.intelgenx.com.
Source: IntelGenx Technologies Corp.
………………………………………………………………………………………………………….……………………………
Would you like to support a project based right here in Quebec?
This book is being co-authored by two people who are passionate about Quebec and everything it has to offer. One of the authors moved to the region some years ago while the other was born and raised in Quebec.
The Québec Book is a unique guide for anyone interested in learning about Quebec culture and the language spoken here. You could be someone visiting Québec, planning to move to Québec, or already living here. Or maybe you’re a native English speaker, a native French speaker, or a speaker of any other language for that matter.
About Author
Write a Comment
Only registered users can comment.
