Optimi Health Granted Amendment Allowing for Increased Quantities of MDMA, MDA, and 2C-B

Optimi Health announced that the end-to-end drug researcher and formulator, was granted an amendment to their Health Canada Controlled Drugs and Substances License, according to a recent press release (1). Through this amendment, Optimi Health will be able to increase the amounts of 3,4-Methyl​enedioxy​methamphetamine (MDMA), 3,4-Methylenedioxyamphetamine (MDA), and 4-Bromo-2,5-Dimethoxybenzene Ethanamine (2C-B), they are able to produce. The reform falls under subsection J.01.059(4) which is located in Part J of the Food and Drug Regulations (1). As stated in their press release, the terms for the allowed increases are (1):

• N-Methyl-3,4-Methylenedioxy Amphetamine (MDMA) – from 2kg to 20kg.
• 3,4-Methylenedioxyamphetamine (MDA) – from 1kg to 2kg.
• 4-Bromo-2,5-Dimethoxybenzene Ethanamine (2C-B) – from 400g to 4kg.

The organization is hoping to position themselves to be a “industry-leading psychedelics drug manufacturer” as they wait for the US Food and Drug Administration (FDA) to approve MDMA, likely to take place in 2024 (1).

“This marks a pivotal achievement in Optimi's strategic licensing plan, positioning us with one of the most robust licensing portfolios globally. It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances,” Bill Ciprick, CEO of Optimi Health, expressed (1).

Optimi Health’s press release disclosed in their year-end Annual Review (1), that they have a “2024 strategic licensing plan which includes approvals for a Drug Master File (DMF) and Drug Establishment Licence (DEL). This critical documentation affirms Optimi’s commitment to regulatory compliance and transparency, laying the foundation for streamlined communication with regulatory authorities and delivering high-quality APIs and controlled substances that meet global standards for pharmaceutical manufacturing and control.”

The drug researcher and formulator are able to produce these controlled substances with Health Canada’s approval (1):

• 2,5-Dimethoxyphenethylamine
• 3,4-Methylenedioxyamphetamine (MDA)
• 4-Bromo-2,5-Dimethoxy-N-(2-Methoxybenzyl)Phenethylamine (25-BNBOME)
• 4-Bromo-2,5-Dimethoxybenzene Ethanamine (2C-B)
• 4-Chloro-2,5-Dimethoxy-N-(2methoxybenzyl)Phenethylamine(25C-NBOME)
• 4-Hydroxybutanoic Acid (GHB)
• 4-Iodo-2,5-Dimethoxy-N-(2-Methoxybenzyl)Phenethylamine (25I-NBOME)
• Harmaline
• Harmalol
• Ketamine
• Lysergic Acid Diethylamide (LSD)
• Mescaline
• N,N-Dimethyltryptamine (DMT)
• N-Methyl-3,4-Methylenedioxy Amphetamine
• Phencyclidine
• Psilocin
• Psilocybin
• Salvinorin A

To learn more about Optimi Health’s precursor license from Health Canada (2), please click here.

References

1. Optimi Health Corp. Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence https://www.globenewswire.com/news-release/2024/01/19/2812249/0/en/Optimi-Health-Secures-Amendment-to-Increase-Quantities-Of-MDMA-MDA-And-2C-B-Under-Controlled-Drugs-And-Substances-Dealer-s-Licence.html (accessed Jan 19, 2024).
2. Colli, M. Health Canada Approves Optimi Health Precursor License to Formulate MDMA and Encapsulate Various Dosages https://www.cannabissciencetech.com/view/health-canada-approves-optimi-health-precursor-license-to-formulate-mdma-and-encapsulate-various-dosages (accessed Jan 19, 2024).