LOS ANGELES- Optimi Health Corp. a Health Canada licensed entity engaged in psychedelic substance research and formulation, has achieved a significant milestone in its operational growth. The company announced on January 16, 2024, an amendment to its Controlled Drugs and Substances Licence by Health Canada. This amendment marks a substantial increase in the permitted quantities of several controlled substances, including MDMA, MDA, and 2C-B.
The specific changes under the amendment include an increase in the permissible amount of N-Methyl-3,4-methylenedioxyamphetamine (MDMA) from 2kg to 20kg, 3,4-Methylenedioxyamphetamine (MDA) from 1kg to 2kg, and 4-Bromo-2,5-Dimethoxybenzene Ethanamine (2C-B) from 400g to 4kg. These adjustments reflect a significant expansion in Optimi’s manufacturing capabilities for these substances.
Bill Ciprick, CEO of Optimi, emphasized the amendment’s role in bolstering the company’s strategic licensing plan, highlighting its importance in positioning Optimi as a global leader in the supply of Good Manufacturing Practice (GMP) MDMA and other psychedelic substances. This development is particularly noteworthy in light of the potential approval of MDMA by the U.S. Food and Drug Administration anticipated in 2024.
Optimi’s year-end Annual Review detailed its 2024 strategic licensing objectives, including approvals for a Drug Master File (DMF) and Drug Establishment Licence (DEL). These documents underscore Optimi’s dedication to regulatory compliance and transparency. They are crucial for maintaining open communication with regulatory bodies and ensuring the production of high-quality Active Pharmaceutical Ingredients (APIs) and controlled substances that adhere to international pharmaceutical manufacturing and control standards.
Following this amendment, Optimi has received Health Canada’s approval to manufacture a wide range of controlled substances, including but not limited to DMT, LSD, Mescaline, Psilocybin, and Ketamine. This expansion of their licensed manufacturing portfolio is a substantial step in the company’s journey to become a leading figure in the global psychedelics market, providing an array of substances for therapeutic and research purposes.
The amendment signifies a major advancement in Optimi’s operational capacity and marks a pivotal point in the company’s strategy to establish itself firmly in the rapidly evolving psychedelics industry. With the increased manufacturing capabilities and the potential broadening of regulatory approvals, Optimi Health Corp. is well-positioned to meet the growing global demand for psychedelic substances, both for medical research and potential therapeutic applications.
