- Optimi Health (CSE:OPTI) confirmed that its formulated MDMA meets Good Manufacturing Practice (GMP) specifications
- The licensed GMP psychedelics pharmaceutical manufacturer stated in a news release it received a Certificate of Analysis from independent third-party laboratory testing
- Optimi has successfully conducted GMP process validation for encapsulating the active pharmaceutical ingredient in 40mg and 60mg dosage variants, with batch capacities reaching 1,000 capsules in GMP production settings
- Shares of Optimi Health Corp. last traded at $0.35
Optimi Health (CSE:OPTI) confirmed that its formulated MDMA meets Good Manufacturing Practice (GMP) specifications.
The licensed GMP psychedelics pharmaceutical manufacturer stated in a news release Tuesday that it received a Certificate of Analysis from independent third-party laboratory testing.
Optimi has successfully conducted GMP process validation for encapsulating the active pharmaceutical ingredient in 40mg and 60mg dosage variants, with batch capacities reaching 1,000 capsules in GMP production settings.
The certificate of analysis for the final product verifies critical information and analysis pertaining to uniform content, microbial and water content as well as dosage potency. Continuous stability assessments by Optimi reveal that the MDMA active ingredient utilized in both dosage strengths maintains stability within the capsules under normal and expedited storage conditions for up to three months.
The MDMA active pharmaceutical ingredient used to produce the releasable GMP capsules has a purity level of 99.95 per cent.
“Our team’s attention to detail enabled us to achieve releasable MDMA capsules that not only meet regulatory and GMP compliance, but also exceed expectations in terms of dosage uniformity, dissolution, and stability. We are thrilled to be one of the only companies in the world with MDMA 40mg and 60mg GMP capsules now available,” Dr. Preston Chase, Optimi’s chief science officer said in a statement.
“Completing the process validation and stability testing underscores our commitment to producing drug candidates that adhere to the highest GMP standards of consistency and reliability,” Bill Ciprick, CEO of Optimi Health, added.
The company’s MDMA ingredient is fully synthesized in-house at its 930-square-metre cultivation and formulation facility in Princeton, British Columbia. The materials used to formulate the product were also obtained through Optimi Health’s Health Canada Precursor License.
Optimi also announced that it intends to close a third and final tranche of its private placement at $0.30 per share for gross proceeds of up to C$1.5 million.
Optimi Health is a Health Canada-licensed psychedelics pharmaceutical manufacturer focused on controlled substances such as botanical psilocybin and MDMA and functional mushrooms that focus on the health and wellness markets.
Shares of Optimi Health Corp. (CSE:OPTI) last traded at $0.35.
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