WASHINGTON, D.C., AL / ACCESS Newswire / October 5, 2025 / As the United States moves closer to officially rescheduling marijuana under the Controlled Substances Act, one company has already spent nearly a decade building what the new regulatory era demands: pharmaceutical-grade cannabis medicines developed under FDA supervision.
MMJ International Holdings, through its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs, is pioneering a scientific pathway that separates medicine from marijuana. The company's research targets two debilitating neurological conditions - Huntington's disease and Multiple Sclerosis - one of which have earned FDA Orphan Drug Designations for MMJ's proprietary cannabinoid soft gel formulations (MMJ-001 and MMJ-002).
A Turning Point for Cannabis Science
After more than fifty years under Schedule I classification, marijuana's reclassification to Schedule III represents more than just a policy shift - it's an invitation to science. For the first time, researchers and pharmaceutical developers can pursue cannabinoid therapies without the crushing weight of Schedule I restrictions that historically paralyzed innovation and investment.
Under Schedule III:
FDA-approved research can move forward with streamlined DEA registration.
Pharmaceutical manufacturing and clinical supply chains become legally sustainable.
Insurance and reimbursement pathways for cannabinoid-based medicines can finally emerge.
Pharmaceutical Partnerships, Global Distribution
MMJ has established exclusive agreements with International producers of pharmaceutical grade cannabis, and Pharmaceuticals, which distributes to several pharmacies across Europe.
These partnerships ensure that MMJ's cannabinoid formulations meet the stringent Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards required for human clinical trials - and ultimately, for prescription medicines.
By leveraging this transatlantic supply chain, MMJ is positioned to lead both U.S. clinical development and European commercialization as the regulatory barriers fall.
FDA Compliance: The Real Differentiator
Unlike companies chasing rescheduling headlines, MMJ has already done the hard work:
Two active IND filings with the FDA.
GMP-certified laboratory infrastructure through MMJ BioPharma Labs.
Pending DEA bulk manufacturing registration (Control No. W18134021E).
Validated pharmaceutical encapsulation technology for precision dosing.
This pharmaceutical approach transforms cannabis from a political issue into a medical innovation platform - one grounded in evidence, ethics, and patient need.
A New Era of Accountability and Access
The U.S. is entering a critical inflection point. Schedule III rescheduling will not only unlock research but also expose which companies truly meet FDA and DEA standards - and which have simply marketed around them.
"Real patients deserve real medicine," Boise added. "MMJ was founded to prove that cannabinoid science, when done properly, can stand alongside any other pharmaceutical therapy. We're not selling marijuana - we're delivering medicine."
About MMJ International Holdings
MMJ International Holdings is a pioneering biopharmaceutical company developing cannabis derived medicinesthrough FDA approved clinical trials. Its subsidiaries - MMJ BioPharma Cultivation and MMJ BioPharma Labs - operate within DEA and FDA regulatory frameworks to produce standardized, pharmaceutical grade cannabinoid formulations for the treatment of Huntington's disease and Multiple Sclerosis.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
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