Posted: Nov 19, 2020 in News

API receives compliant Drug Establishment Licence inspection from Health Canada

web health canada

The Drug Development and Innovation Centre GMP facility has received a notice of compliance for a Drug Establishment Licence (DEL) following an audit by Health Canada.

“This is a huge step forward for API’s efforts to develop security of supply manufacturing and support innovators in the commercial market.” says CEO, Andrew MacIsaac, “Over the past 9 months we’ve been working around the clock to bolster our capacity to meet needs related to Covid-19 and we’ve now passed this significant milestone.”

While API’s facilities were previously appropriate for clinical trials, a DEL will enable the organization to work with products that are on the market – a critical licensing step in the efforts of API to establish production of Propofol and other drugs.

“The successful audit is 100% due to the expertise and hard work of Dr. Vijay Somayaji as well as centre director Dr. Raimar Löbenberg.” says Andrew, “We’ve now got everything in hand to expedite the launch of products from our planned facility once it is funded.”

API and regional economic development organization Edmonton Global are currently advocating for federal and provincial funds towards a 40,000 square foot manufacturing facility that API and a consortium of partners can use to address drug shortages as well as transform the ability of Canada to support innovators taking new drugs clinical trials and beyond. The facility will play a key role in building up Alberta’s pharmaceutical manufacturing industry and eliminate the need for companies from across Canada to move operations out of the country as they progress through the drug development process.

Posted by: API

On Nov 19, 2020 in News