Native American Cannabis Company Partners with Extraction Tech Leader to Achieve FDA and EU GMP Compliance
This strategic move positions Refined to capitalize on the imminent rescheduling of marijuana as a Schedule III controlled substance by the DEA, which would allow for interstate commerce and international distribution of cannabis-based pharmaceuticals.
Refined Processes LLC, a pioneering Native American-owned cannabis oil processing company, has entered into a strategic partnership with Prodigy Processing Solutions, a leading innovator in GMP-compliant cannabis extraction technology. This collaboration aims to establish the first fully FDA cGMP and EU GMP-certified pharmaceutical-grade cannabis extraction facility in the United States.
Located on the Santa Ysabel Reservation in California, Refined is upgrading its operations to meet stringent good manufacturing practice (GMP) standards mandated by the FDA and European Union for biotech and pharmaceutical research, development, manufacturing, and production of cannabis oil extracts.
This strategic move positions Refined to capitalise on the imminent rescheduling of marijuana as a Schedule III controlled substance by the DEA, which would allow for interstate commerce and international distribution of cannabis-based pharmaceuticals.
"The likelihood of rescheduling is almost certain," stated Marc Beginin, veteran cannabis attorney and CEO of Prodigy. "The DOJ initiated the formal rescheduling process on May 21, 2024. Cannabis could be a Schedule III drug by September."
To seize this global market opportunity, Refined is retrofitting its existing lab with Prodigy's advanced GMP-compliant extraction equipment and actively negotiating supply agreements with compounding pharmacies in the U.S. and distribution partners in the EU, Australia, and Pacific Rim under its Sugar Bear Cannabis brand.
"Our partnership with Prodigy enables us to leverage their cutting-edge technology and expertise in GMP-compliant extraction to broaden our reach and impact globally," said Aaron Thomas, CEO of Refined and seasoned cannabis veteran.
Prodigy's USA-made extraction systems, constructed from 316L pharmaceutical-grade stainless steel, are designed to meet or exceed the most stringent international GMP standards for the life sciences industry.
"By upgrading to FDA cGMP and EU GMP compliance, Refined is strategically positioning itself ahead of all other U.S. cannabis extraction operations to engage with pharmaceutical and biotech companies upon DEA rescheduling," Beginin added.
This first-of-its-kind partnership cements Prodigy as the premier provider of GMP-compliant life science solutions for the cannabis extraction sector.
The companies invite other tribes, labs, pharmaceutical firms, and biotech companies to explore collaborative opportunities that leverage their combined expertise to elevate processing standards worldwide.
