Optimi Health Corp (CSE:OPTI, OTCQB:OPTHF) announced it received a Certificate of Analysis from an independent, third-party laboratory testing that confirms its formulated MDMA meets Good Manufacturing Practice (GMP) specifications.
The company said on Tuesday it had also completed GMP process validation for the encapsulation of the active pharmaceutical ingredient (API) in both 40mg and 60mg dosage formats for batch sizes up to 1,000 capsules during GMP production.
It said the Certificate of Analysis confirms important data and analytics for the finished product’s content uniformity, microbial and water content, and dosage strength.
The company also pointed out that its ongoing stability testing has shown that the MDMA API used to make both dosages remains stable within the capsules in real-time and accelerated storage conditions for up to three months.
The MDMA API used to produce the releasable GMP capsules has a purity level of 99.95%, it said.
“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,” commented Dr Preston Chase, Optimi’s chief science officer.
“We are thrilled to be one of the only companies in the world with MDMA 40mg and 60mg GMP capsules now available.”
Bill Ciprick, Optimi CEO, highlighted that the company’s dedication to quality and reliability drives every aspect of its operation.
“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,” Ciprick said.
Further, Optimi Health announced that it intends to close a third and final tranche of its non-brokered private placement.
Its offering consists of units priced at C$0.30 each for gross proceeds of up to C$1.5 million.
It raised C$555,010 in the first tranche and C$400,000 in the second tranche of the offering, which closed on February 23 and May 10, respectively.
Each unit consists of a share and one-half of a share purchase warrant, with each warrant entitling the holder to acquire a share for C$0.40 for two years, subject to certain conditions.
British Columbia-based Optimi Health is a leading Health Canada-licensed GMP psychedelic pharmaceutical manufacturer specializing in controlled substances such as botanical psilocybin and MDMA.