Albert Labs International Corp (CSE:ABRT) said it has been granted a Health Canada license for its research and production facility in Burnaby, Canada, which gives it permission for the legal possession, production, assembly, sale, and delivery of psilocybin and other psychoactive controlled substances.
The research and drug development company cultivates, extracts, and processes pharmaceutical-grade natural psilocybin. Using patent-pending technology, it can optimize the consistency and standardization of natural psilocybin Active Pharmaceutical Ingredients (APIs) to meet regulatory compliance standards.
Albert Labs said the licence enables it to distribute API to Canada and, where import licenses exist, internationally. The licence will allow the company to supply product to its forthcoming Real World Evidence (RWE) trial in the UK, as well as distribute and sell API to other licensed customers.
Under Health Canada’s Special Access Program (SAP), the company is also able, once a medicinal product is approved, to provide health care professionals with medicines under prescribed conditions.
READ: Albert Labs says completing safety studies ahead of upcoming clinical trials involving its psilocybin-based product candidate KRN-101
"This is an important milestone for Albert Labs; it firms up our supply chain and provides us with more market opportunities," Dr Michael Raymont, CEO of Albert Labs said in a statement.
“With this license, we now have the flexibility to produce and supply precursor APIs to our own operations in Europe and to explore sales to other customers in Canada and elsewhere."
Endorsing Health Canada for its leadership in creating a favourable regulatory environment for advancing therapeutic uses for psilocybin, Raymont added: "The Canadian government has created a beneficial environment for business to develop psychotherapeutic prescription drugs, which have the potential to help millions of sufferers with anxiety, depression and other mental health indications.
“Mental health issues can ruin lives, wreck families, and cost economies billions in lost productivity. It's inspiring to see Canada as a leader in mental health R&D and treatments."
Albert Labs is a Vancouver-based clinical research and drug development enterprise that is fast-tracking the development of mental health medicines with its focus on real-world evidence.
Contact the author at jon.hopkins@proactiveinvestors.com