DENVER--(BUSINESS WIRE)--MedPharm Research, a wholly owned subsidiary of MedPharm Holdings, a leading medical cannabis manufacturer, R&D laboratory, and compounding facility, announces that they have been approved for a Drug Enforcement Administration (DEA) Schedule I Researcher License.
Having this license from the DEA means that MedPharm Research is authorized to possess and use cannabis related Schedule I substances for research purposes, which includes the ability to ship investigational medications over state lines for clinical trials.
The process for approving the license is rigorous, involving specific protocols from the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), which reviews applications sent from the DEA. The DEA makes the final determination on approving applications for research using schedule I substances and drugs.
Obtaining approval for this new license represents another impressive win for MedPharm as it continues to grow its research capabilities and enhance its leadership position in the cannabis industry.
“It’s been a long road to getting a federally approved license,” Albert Gutierrez, CEO of MedPharm Research, says. “We are thrilled and honored that the DEA saw the importance and significance of the work we do at MedPharm. We proved to them that we deserve this license.”
The DEA license enables MedPharm Research to isolate and evaluate the activity of phytocannabinoids on different brain cells (such as neuron, astrocytes, microglia). The goal of the process is to markedly improve isolation and purification methods for cannabinoids, and to systematically examine the effects of single compounds as well as complex mixtures on the different cell types that make up the brain during normal and diseased states.
It also makes the company the ideal partner for researchers seeking to study cannabis.
According to Duncan Mackie, PhD, the director of pharmacology and experimental therapeutics for MedPharm, the license allows MedPharm to study all of the more than 400 molecules known to be made by the cannabis plant. “These are the first steps in the drug discovery pipeline that MedPharm Research is establishing with the goal of pushing cannabinoid research towards a more translational foundation, where interesting chemical compounds from a basic sciences viewpoint can be translated into a more applicable state that directly benefits human health,” Mackie says.
“The acquisition of this research license comes at a time when the DEA is beginning to allow for new bulk manufacturers of cannabis and cannabis products. This means that there will be more varieties of cannabis available that are of higher quality than what has been available to date,” says director of chemistry and research, Tyrell Towle, PhD. “Access to the diversity of chemicals produced by cannabis has never been greater and we are excited to unlock the medical potential of these compounds.”
MedPharm has a 15,000-square-foot manufacturing, research and development laboratory and cannabis processing facility in Denver, Colorado. Since beginning operations in 2017, MedPharm has grown to a staff of 44 people. The company provides cannabis pharmaceutical-type products in a certified current Good Manufacturing Practices (cGMP) and Good Agricultural Practices (GAP) facility that includes cultivation, pre-formulation, formulation development, small scale commercial manufacturing, analytical method development and validation, routine quality control analysis and stability studies. MedPharm creates pharmaceutical-grade dosage forms and produces ingredients utilizing pharmaceutical technology to be used in the delivery of cannabis compounds. The company specializes in neuropharmacology with a focus on Alzheimer’s disease and dementia. More information can be found about MedPharm at: www.medpharmholdings.com.