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Saturday, Dec 9, 2023
Mugglehead Magazine
Alternative investment news based in Vancouver, B.C.


Optimi receives amendment from Health Canada permitting MDMA production

Vancouver producer to supply synthetic psychedelic compounds to designated investigators and companies

Optimi Health submits clinical trial application after developing proprietary MDMA drug
Optimi Health staff involved in the production of OPTI-MHCL. Photo via Optimi Health

A British Columbia-based company will soon have a heavier workload after gaining approval to expand its catalogue of regulated products and distribution channels within the psychedelic sector.

On Tuesday, Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) announced that it had received permission from Health Canada to manufacture and distribute MDMA and a series of other psychedelic substances under the newly amended terms of an application submitted to the government department in June.

The company is scheduled to commence analytical testing and production of MDMA in October.

Read more: Short Wave and Sheba partner for clinical trial aimed at combatting anorexia

Read more: Lobe Sciences partners with iNGENū for new clinical trials in Australia

Optimi is a Canadian company with a Health Canada license to develop and distribute high-grade natural psilocybin in adherence to European Union good manufacturing practices (EU-GMP), an internationally recognized standard. The organization owns and operates two 20,000-square-foot production facilities in Princeton, B.C., making Optimi the largest psilocybin and MDMA cultivator in the continent, according to the company.

The terms of the new amendment came into effect on August 5, and the facilities in Princeton will inherently be accelerating their overall production rate to help accommodate an evolving market with new products.

The company says that since the amendment request for its Controlled Substances Dealers License was submitted in June it has received an immense amount of interest from industry stakeholders, clinical trial researchers and drug developers intrigued by Optimi’s production potential. The drug producer says that this growing interest has reaffirmed the company’s choice to proceed with the new phase of its commercialization plan.

Optimi’s CEO says that the organization’s in-house production capacity for a broad range of formulations will position the company as a leader in the commercial production and distribution of psychedelics.

“From lab to market, Optimi has taken every step necessary to build its competitive position as a global leader in the manufacturing of EU-GMP compliant MDMA in North America, and we’ve done that through operational transparency and investing in smart infrastructure,” said Bill Ciprick, CEO at Optimi.

“On compliance, quality, and scale, we have consistently demonstrated our plan to lead the industry in API synthesis and formulation, which gives our science and operations team the confidence to develop saleable psychedelic products that are supported by rigorous in-house Standard Operating Procedures (SOP),” added Ciprick.

Additional substances that Optimi has now received approval from Health Canada to produce and distribute include DMT, LSD, mescaline and salvia divinorum.

Optimi also states that the growing number of MDMA clinical trials in the U.S. and Canada (130 currently listed), recent legal policy changes in B.C. and the newly developed interest in psychedelic regulation from the Biden Administration have made the company anticipate continued growth going into the future.

“The regulatory landscape in the U.S and Canada is always evolving, specifically with the Canadian government’s recent decision to decriminalize MDMA up to 2.5 grams in British Columbia,” said Optimi’s Regulatory Affairs Advisor, Michael Kydd.

“Governments often use incremental shifts in policy to test public sentiment, which sometimes triggers broader policy change down the road. Having a license to produce EU-GMP MDMA at an unmatched scale will benefit the Company when we eventually see these wholesale policy changes,” added Kydd.


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