MMJ International Holdings Submits FDA Responses For Cannabis Gel Capsule Approval
WASHINGTON, D.C. / ACCESSWIRE / September 20, 2023 / MMJ International Holdings announced today, that it has submitted to the U.S. Food and Drug Administration (FDA) MMJ’s cannabis formulation requested responses for the agency’s review. The FDA had notified MMJ International Holdings of a CMC (chemistry, manufacturing, control) issue which the company completed the required complex scientific research needed to begin its clinical trials in Multiple Sclerosis and Huntington’s Disease.
Dr. Elio Mariani, MMJ’s chief scientific stated, “MMJ believes that the responses submitted to the FDA today fully addresses the CMC questions pertaining to its all-natural plant, soft gel capsule API of THC and CBD, for use in human clinical trials.”
Duane Boise, President stated, “Once approved, MMJ International Holdings, MMJ BioPharma Cultivation, and MMJ Biopharma Labs will be one of a very few federally legal DEA, FDA approved companies, vertically integrated, with the infrastructure to support pharmaceutical development of botanical drugs for clinical trials.”
MMJ BioPharma Labs has been issued a DEA Analytical Lab Registration for schedule 1 drugs with the primary focus on cannabis research and development. With this DEA approval, MMJ Biopharma Labs becomes one of the few federally legal labs dedicated to cannabis extraction, research, and development.
This DEA approval allows MMJ BioPharma Labs the ability to manufacture, transport, import, and export cannabis domestically and internationally to DEA registrants and companies registered in their respective international jurisdictions.
In spite of all these accomplishments and President Biden’s Marijuana Research Act approval the DEA continues to delay MMJ BioPharma Cultivations API Bulk Manufacturing registration approval which is the subject of litigation.
Tim Moynahan, chairman stated “MMJ has accomplished many major milestones which positions it as a leader in the cannabis pharmaceutical development arena. This being the most significant because safe, reproducible marijuana medicine is needed to set the standard for reproducible results. MMJ’s clinical trials will prove efficacy and this is what the team has accomplished.”
MMJ recognizes that there is significant public interest in cannabis and cannabis-derived compounds. The MMJ team continues to work diligently with universities and scientist to fill in the knowledge gaps about the science, safety and quality of their products. We are committed to advancing our marijuana cultivation, lab formulations and clinical trials through an approach that is in line with our mission to prioritizes public health, fosters innovation, and promotes consumer confidence.
Duane Boise the companies President recently speaking at the Benzinga Cannabis Forum mentioned that “as federal legalization of the state to state recreational and medicinal marijuana businesses is not imminent, MMJ’s strategy of pharmaceutical drug development and clinical trials will show itself as the new cannabis 3.0.”
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
media@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
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