Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a Health Canada licensed drug researcher and formulator specializing in controlled psychedelic substances such as natural psilocybin and MDMA, is pleased to announce it has been granted an amendment to its Health Canada Controlled Drugs and Substances Licence. Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.

Terms of the amendment now permit the following increases:

  • 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 obtained amendment is a crucial component of Optimi’s strategy to solidify its position as an industry-leading psychedelics drug manufacturer, strategically positioning itself in anticipation of the potential approval of MDMA by the U.S. Food and Drug Administration in 2024.

“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, Optimi’s CEO

In its year end Annual Review, the Company laid out its 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.

Optimi now has Health Canada approval to manufacture the following controlled substances:

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

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