LOS ANGELES- Optimi Health, a Canadian company specializing in psychedelic drug research and formulation, has achieved a significant milestone with Health Canada’s approval of an amendment to its Dealer’s Licence. This crucial development allows Optimi to commence the official supply process for Canada’s Special Access Program (SAP), under the guidelines of the Controlled Drugs and Substances Act and its Regulations.
Navigating the stringent licensing regulations in Canada, Optimi Health has adeptly overcome the regulatory challenges to supply MDMA and Psilocybin Drug Candidates, crucial for therapeutic use. These candidates are produced under the rigorous standards set by the Company’s Licence, aligning with the stringent requirements of Health Canada’s Office of Controlled Substances Division.
Bill Ciprick, CEO of Optimi, expressed optimism about the company’s trajectory in supplying the SAP. He highlighted the company’s relentless commitment over recent months, which has significantly bolstered their capabilities in Good Manufacturing Practice (GMP) psychedelics production. “Our consistent dedication has been instrumental in ensuring that our in-house formulated drug candidates will soon be accessible to healthcare professionals for the therapeutic benefit of their patients,” stated Ciprick.
Emphasizing the critical role of accountability in GMP supply, Karina Lahnakoski, Director of Quality and Commercial Strategies at Optimi, pointed out the importance of safety, scale, and quality in their operations. “These factors are vital in our endeavor to meet the needs of practitioners not only in Canada but also in Australia,” Lahnakoski said, underscoring the company’s commitment to maintaining the highest standards in their products.
This development marks a significant step forward for Optimi Health, positioning the company as a key player in the burgeoning field of psychedelic therapy. Their success in obtaining this amendment reflects their adherence to quality and regulatory compliance, setting a precedent for future advancements in the field of psychedelic medicine.
