US Pharmaceutical Cannabis Extraction Facility to Open

Prodigy Processing Solutions, an innovator in GMP-compliant cannabis extraction technology, and Refined Processes LLC, a pioneering cannabis oil processing company, announced a new partnership. The collaboration aims to establish the first fully GMP (Good Manufacturing Practices)-compliant pharmaceutical cannabis extraction facility in the US.

Located on the Santa Ysabel Reservation in California, Native American-owned Refined is upgrading its operations to be FDA cGMP and EU GMP compliant for biotech and pharmaceutical research, development, manufacturing, production, and chemical separation of cannabis oil extracts.

This strategic move is in direct response to the much-anticipated rescheduling of marijuana to a Schedule III controlled substance by the US Drug Enforcement Administration (DEA), which will allow for interstate commerce of cannabis as an FDA-approved prescription drug and international distribution to nations that have legalized cannabis for medical or recreational purposes.

With the support of the US Department of Justice (DOJ), Department of Health and Human Services (HHS), and White House Office of Management and Budget (OMB), “the likelihood of rescheduling is almost certain,” said Marc Beginin, veteran cannabis law attorney and CEO of Prodigy. “The DOJ initiated the formal rulemaking process on rescheduling on May 21, 2024. My bet is cannabis will be a Schedule III drug by this September.”

To seize this opportunity, Refined is upgrading its existing processing lab with Prodigy's advanced GMP-compliant extraction equipment to meet worldwide pharmaceutical standards. It is also in active negotiations with compounding pharmacies in the United States and distribution partners in the EU, Australia, and the Pacific Rim, poised to supply both precursor extracts and finished products under its retail brand, Sugar Bear Cannabis.

"Our partnership with Prodigy enables us to leverage their cutting-edge technology, and deep expertise in cannabis extraction and GMP compliance, to broaden our reach and impact," said Aaron Thomas, CEO of Refined. "Our commitment to uniting the tribes of America through high-quality cannabis products distributed globally is brought one step closer by this partnership."

Thomas, a cannabis industry veteran and chemical engineer, boasts a distinguished track record of consulting, constructing, and managing numerous successful cannabis enterprises throughout California. His visionary approach now sets its sights on revolutionizing cannabis oil extraction by Native American tribes.

Prodigy's USA-made extraction equipment, forged with 316L pharmaceutical stainless steel with full material traceability, meets or exceeds global GMP standards.

"By upgrading its lab to meet FDA cGMP and EU GMP compliance, Refined and its sovereign Tribal nation partners are positioning themselves well ahead of all other U.S.-based cannabis extraction and processing operations," Beginin said. "Refined is strategically positioning itself to engage in business with U.S. and international pharmaceutical and biotech companies upon DEA rescheduling."