The Most Comprehensive Cannabinoid Portfolio on the Market
With a strong focus on the development, manufacture, and deployment of advanced cannabinoid ingredients, Purisys maintains the broadest cannabinoid portfolio on the market – with experience producing commercial quantities of high-quality ingredients that goes back over 10 years. Purisys began working with a Drug Master File for Dronabinol (Δ9-THC) (DMF 20682) in 2007. Since then we have added a US DMF for CBD (2020) and a Canadian DMF for Nabilone (2020). Additional cannabinoids produced by Purisys have been used in IND filings throughout the world.
Today, Purisys produces multiple major and minor cannabinoids – more than 50 – as well as degradants, metabolites, and analytical standards to help our customers different themselves in the marketplace.
Commercially Validated Cannabinoid API’s
Purisys has been manufacturing cannabidiol since 2016 (DMF33223). Today, we have the ability to produce GMP synthetic CBD on the largest commercial scale in the world. Our ultra-high purity CBD is attractive for drug development projects and falls significantly below the 0.3% THC limits set in the 2018 Farm Bill for use in consumer products. Purisys’ CBD has THC levels that are < 0.001%. Purisys’ patent-protected manufacturing process produces a consistently odorless, tasteless white powder, highest-purity form of CBD that exhibits the same biological attributes as extracted CBD without the risk of containments such as pesticides, heavy metals and undesired cannabinoids that were not purged during isolation and extraction.
Purisys has been manufacturing dronabinol in sesame oil (generic for Marinol) since 2007. Our THC is highly pure and used in a variety of pharmaceutical markets. This innovative technology has allowed Purisys to begin to expand our THC portfolio to include different carrier oils and solvents.
Nabilone is an unnatural cannabinoid that is also manufactured commercially by Purisys. Our efficient route allows us to produce high quality Nabilone at a commercial price point well below our competition.
Purisys manufactures our commercial API’s according to cGMP (ICH Q7 and applicable sections of 21 C.F.R. Parts 210 and 211). We use validated analytical test methods and rigorous quality systems for this ingredient.
So-called ‘rare cannabinoids’ are only rare in nature. Today, kilogram quantities of rare cannabinoids can be manufactured in high purity, physically stable form under cGMP conditions. Use of this technology platform can unlock these compounds for human clinical use. Clinical stage supply is available for multiple rare cannabinoids. Purisys will continue to add cannabinoids to our portfolio in alignment with market demand.
Purisys manufactures CBD according to cGMP (ICH Q7 and applicable sections of 21 C.F.R. Parts 210 and 211).
LIST OF HEALTH AND RELATED CLAIMS UNDER INVESTIGATION