Purisys provides access to the broadest portfolio of custom and naturally equivalent, synthetically produced cannabinoid APIs, reference standards, and analytical services in the pharmaceutical industry.
Today, Purisys produces major and minor pharmaceutically compliant cannabinoids as well as degradants, metabolites, and analytical standards to help our customers differentiate themselves in the marketplace. 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 and US DMF for Nabilone in 2020 and 2022, respectively. Additionally, pharmaceutically compliant cGMP cannabinoids produced by Purisys have been used in IND filings throughout the world.
Purisys has been manufacturing cannabidiol (CBD) since 2016 (DMF33223). Today, we have the ability to produce GMP synthetically derived 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. Purisys’ CBD has THC levels that are non-detectable by conventional analytical methods. 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 contaminants, such as pesticides, heavy metals, molds, and undesired cannabinoids that were not purged during isolation and extraction. We have compared our product with naturally sourced CBD, and the two are identical. Purisys’ Cannabidiol API is stable for at least 4 years at room temperature in conventional packaging as proven by ICH-compliant stability studies.
Purisys has been manufacturing dronabinol (Δ9-THC) in sesame oil (generic for Marinol®) since 2007. Our dronabinol is highly pure and used in a variety of pharmaceutical markets including clinical stage research. This innovative technology has allowed Purisys to begin to expand our THC portfolio to include different carrier oils and solvents as well as a pure resinous substance with multiple years of stability at room temperature.
Nabilone is a synthetically derived cannabinoid that cannot be found in plants and is also manufactured commercially by Purisys for use in generic forms of Cesamet™. Our efficient, proprietary route allows us to produce high-purity Nabilone robustly and cost-effectively.
Purisys manufactures our commercial APIs 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 for pharmaceutical purposes. Use of our proprietary, synthetic technology platforms 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.
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