Pharmaceutical oils for Cannabinoid drug products – White Paper
There are currently more than 150 cannabinoid-based products under development in the world. The first US FDA approved product Epidiolex®, isolated from the cannabis plant and indicated for severe forms of epilepsy is formulated with Sesame oil. Other approved products like Marinol® are also formulated with oils.
Cannabinoids, generally, have a very low solubility in water and are highly lipophilic. Among the hundreds of phyto-cannabinoids in cannabis, tetrahydrocannabinol (THC) and cannabidiol (CBD) have been studied in many different therapies.
ADM portfolio for the formulation of your Cannabinoids drug products
ADM´s highly purified oils are fully compliant with the European Pharmacopoeia (EP) and United States Pharmacopeia/National Formulary (USP/NF) monographs and general notices intended for use in the manufacturing of pharmaceutical products.
Manufactured under cGMP according to ICH-Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients or to the Joint IPEC-PQG Good Manufacturing Practice Guidance for Pharmaceutical Excipients.
Supported with Certificate of Suitability to the European Pharmacopoeia (CEP) granted by the European Directorate for the Quality of Medicines & Healthcare (EDQM) and/or with Drug Master File (DMF) type IV for excipients submitted to the U.S. Food and Drug Administration (FDA).
See the ADM white paper: “Pharmaceutical oils for Cannabinoid drug products” here
(click the picture to download the brochure)
Source: ADM brochure “ADM White Paper – ADM-SIO Pharmaceutical oils for Cannabinoid drug products”
ADM Quality & Compliance – From Source to Final Product
With more than a century of experience, dedicated production lines and specialized R&D and regulatory teams, ADM offers its customers innovative global solutions tailored to the specific challenges of the pharmaceutical industry. At ADM, we offer a range of products that meet major relevant pharmaceutical regulations and are manufactured according to appropriate cGMP standards. We make delivering compliance and consistency a reality, giving you an edge to innovate with confidence. We are committed to providing only the purest and highest quality products for your end solutions.
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