Ultra-High Purity, Pharmaceutical-Grade CBD and Other Derivatives Are Available for Clinical Study and Broad Range of Pharmaceutical and Consumer Products
Athens, GA 21, November 2019: Purisys, LLC, the leader in ultra-high purity cannabinoids, announced today that the U.S. Drug Enforcement Agency has removed its Cannabidiol (CBD) from Schedule I of the Controlled Substances Act. Purisys currently produces all major cannabinoids relevant to pharmaceutical and consumer products (>50), as well as degradants, metabolites and analytical reference standards. In addition to CBD, more than 30 other cannabinoids have also been descheduled. Purisys has been manufacturing ultra-high purity CBD (<0.001% THC) via a patented process since 2016, and its products fall far below the 0.3% THC limits set in the 2018 Farm Bill for use in consumer products. The cannabinoids produced by Purisys are distinguished by their ultra-low THC concentration, purity, world-scale capacity, exacting quality control, ease of formulation compared to hemp-derived isolates, and strong regulatory support.
According to Jim Mish, CEO of Purisys, the descheduling of its cannabinoids will encourage research with these ultra-pure ingredients and, based on sound clinical and safety studies, create a broader path for their use in pharmaceutical and consumer products. “At Purisys, we are excited about the findings of the DEA with respect to our cannabinoid ingredients. We look at this descheduling as recognition of the consistent purity and quality we can achieve,” he said. “Now that our products no longer are subject to DEA Schedule I status, our customers in the pharmaceutical, personal care and food and beverage spaces are able to more easily conduct the research that will be important to the use of cannabinoids in a wide range of products. At Purisys, we stand ready to back this research, with our applications support, analytical reference standards and small-scale cGMP manufacturing. Of course, this is backed by our world-scale supply capability for commercial production,” he said.
A change in how cannabinoids are handled
According to Tim Jones, Vice President of Global API and OTC for Purisys, the descheduling of these compounds will ease the regulatory compliance activities by companies developing consumer products. “DEA descheduling formally states that our cannabinoids are no longer subject to U.S. DEA controls that affect quotas, aggregates, secure vault storage and more. Descheduling means our customers no longer need DEA registrations to work with Purisys materials,” he said.
A focus on advanced cannabinoids
On October 1st of this year, Purisys, LLC was formed as a spinoff of a leading pharmaceutical API company. It will now focus exclusively as a broad-range ingredient and solutions provider to pharmaceutical and consumer products companies looking to use CBD and other cannabinoid-based ingredients. These solutions are targeted toward pharmaceutical, personal care, OTC, food and beverage and nutritional supplement markets as regulations allow. The new Purisys organization brings one of industry’s longest track records and broadest offerings in the cannabinoid space.
An equally important part of the Purisys offering to customers in the pharmaceutical and consumer products spaces is the range of support services the company can provide for product development. Purisys brings decades of world-class experience in the pharmaceutical market. For consumer products, Purisys has been and will continue to invest in applications development capabilities – including equipment and personnel. These capabilities will range across personal care, OTC, food, beverage and nutritional supplement markets. The company currently has a number of projects under development in the consumer space that feature its ultra-pure CBD.
Headquartered in Athens, Georgia, Purisys was formed with one global goal in mind – to provide pharmaceutical and consumer product companies with the most comprehensive and sustainable array of resources for commercialization of cannabinoids available today. Purisys ingredients are developed using state-of-the-art manufacturing technologies for a broad range of cannabinoids on both small and large scales to create a reliable supply chain to support pharmaceutical and consumer product development and launch – at the highest levels of quality and within cost structures required for successful product commercialization. With roots that stretch back decades in the pharmaceutical industry, the company has a successful regulatory track record in the pharmaceutical industry – and a commitment to consistency and quality is carried over to our work with consumer products.