MMJ BioPharma Cultivation, a cannabis company, received its DEA schedule 1 Analytical Lab Registration, which allows for the international importation of cannabis for research and development.
In addition, MMJ BioPharma has been awarded FDA “Orphan Designation” for its clinical trial in Huntington’s Disease. The company also has an investigational new drug (IND) application filed with the FDA to begin clinical trials in Multiple Sclerosis. Meanwhile, MMJ is awaiting the DEA to issue its bulk manufacturing registration.
“MMJ has filed suit against the DEA for dragging their feet on the matter of not issuing the registration in a timely manner. Currently, MMJ BioPharma is nearing completion of its state-of-the-art, marijuana center of excellence,” stated the firm in a press release on Tuesday.
"As MMJ International Holdings continues to advance to its clinical trials, these DEA delays are unprecedented," stated Elio Mariani, Ph.D., CEO of MMJ. "The statutory mandate of the DEA is security and divergence and to facilitate the manufacturing of pharmaceuticals to help patients suffering from chronic disease."
In addition, MMJ announced that it has executed a contract with “one of the most innovative providers of advanced cultivation solutions in the cannabis industry.”
The Agreement
Under terms of the engagement, the agricultural solutions company will provide several hundred growing modules for MMJ BioPharma’s DEA Schedule 1 Bulk Manufacturing Licensed Facility in Westerly, Rhode Island.
“With the sophistication of this advanced precision cultivation and monitoring technology, MMJ will be able to reproduce quality cannabis, thus meeting the DEA’s marijuana definition of chemical reproducibility and quality, noted Duane Boise, president of MMJ. “To date, other DEA awarded registrants have not demonstrated this capability. Providing this solution allows strain-specific research and collection of advanced data analytics of the cultivation process in order to produce our treatments. There is no other technology on the market that offers precision and reproducibility.”
All controlled environmental growing units come equipped standard with end-to-end production planning software. This will provide consistent cannabis-plant chemical reproducibility within extremely tight tolerances.
Following receipt of their DEA pending cultivation registration, MMJ plans to roll out in three phases. The pharmaceutical-grade cannabis product grown can go directly to research MMJ BioPharma’s on-site lab to be formulated. Subsequently, it will be sent to the manufacturing of the soft gel capsules.
“Once FDA approved, will then be used in human clinical trials. Upon producing successful human trial results, MMJ BioPharma will have its first FDA-approved, full-spectrum, non-synthetic cannabinoid pharmaceutical drug,” stated the firm.
‘Unprecedented Control Over The Cultivation Process’
“Using this advanced cultivation solution and integrated software, MMJ BioPharma will have unprecedented control over the cultivation process, coupled with the most advanced precise data analytics,” Dr. Mariani said.
“This will allow us to isolate strain-specific plants to research and guarantee pharmaceutical-level consistency, quality, and reproducibility to reach scientifically meaningful conclusions,” added Mariani.
“This will be monumental for cannabis and for the people suffering from these debilitating conditions. We’re proud to be a forward-thinking company developing potential pharmaceutical treatments using advanced technologies,” concluded the CEO.
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