"Bulk Manufacturing Permit." The DEA is currently processing the company's application so it can proceed with the FDA-required evaluation and research.
ST. PETERSBURG, Fla. (PRWEB) March 12, 2021
MMJ International Holdings, the premier medical cannabis research company, announced that it is completing the FDA required manufacturing of its proprietary THC and CBD gel cap medicine. MMJ International Holdings is developing a non-synthetic oral drug product from the marijuana plant extracts. MMJ will be utilizing its new product for an FDA-approved treatment of multiple sclerosis (MS), and Huntington's disease (HD) for its clinical trials once approved.
Most recently, MMJ International Holdings received a DEA permit to import its cannabis proprietary extracts into the United States for potential therapies for Huntington's Disease and Multiple Sclerosis. After a considerable amount of work, the team has reach several milestones by developing its proprietary scientific extraction process to optimize and characterize both THC and CBD for its drug formulation. One specific milestones was the FDA Orphan award for Huntington's disease. The companies have been cooperating with multiple government agencies, including FDA, DEA, U.S. Customs and Border Protection (CBP), Health Canada, and the Center for Drug Evaluation and Research (CDER), to accomplish its mission.
To smooth the regulatory pathway, the DEA has recently stated, "DEA anticipates that additional strains of marihuana will be produced and made available to researchers. This should facilitate research, advance scientific understanding about the effects of marihuana, and potentially aid in the development of safe and effective drug products that may be approved for marketing by the Food and Drug Administration.
MMJ International Holdings has executed a supply agreement with MMJ BioPharma Cultivation, who's has filed an application with the DEA for a "Bulk Manufacturing Permit."The DEA is currently processing the company's application so it can proceed with the FDA-required evaluation and research.
"As MMJ International Holdings continues to advance to its clinical trials, a specialty pharmaceutical solutions company has supported MMJ with the FDA, DEA required development for its specialized liquid encapsulation manufacturing," said Elio Mariani, Ph.D., in charge of research & development... "Patients will benefit from cGMP-quality therapies in an accessible and efficient format. We firmly believe that our MMJ oral gel cap medication, containing the marijuana plant's unique pharmacological properties, will be FDA-approved as a safe and effective drug," he further stated.
"Our accomplished team has worked within the FDA guidelines to accomplish the Federal required evaluation and research. MMJ now is concluding our oral gel cap medication's manufacturing process to hopefully obtain FDA approval to proceed to clinical trials in the United States," said Duane Boise, CEO of MMJ International Holdings."MMJ's clinical trials will provide patient dosing, safety, and efficacy data to the FDA to prove that cannabis can treat the debilitating effects of Multiple Sclerosis and Huntington's Disease",
Tim Moynahan, MMJIH chairman, mentioned, "We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work with the FDA And DEA to fill in the knowledge gaps about the science safety and quality of MMJ's products. We are committed to advancing our product development through an approach that is in line with our mission to prioritizes public health, fosters innovation, and promotes consumer confidence."
MMJ International Holdings continues its process of scientific drug development and discovery by following the FDA development processes and the DEA regulatory manufacturing guidelines.