The company has obtained patents for chemical synthesis of Dronabinol, Cannabidiol and derivatives in high yield and high stereospecificity
Noramco is moving forward with a broad offering of clinical- to commercial-scale cannabinoid APIs for branded and generic pharmaceuticals. The comprehensive offering includes everything a drug manufacturer requires to advance cannabinoid-based APIs to finished dosage forms. More than 100 active clinical trials are in progress involving cannabinoids, most focussing on Dronabinol (THC) and Cannabidiol (CBD).
“Therapeutic benefits are established for several cannabinoid compounds, and today pharmaceutical companies require a robust partner to ensure regulatory approval and commercial supply,” said Bill Grubb, Vice President Global Strategy and Innovation, Noramco.
“To help clinicians and drug development companies progress potentially life-changing drug development, we are leveraging assets, expertise, and intellectual property to provide customers a sound solution, seamlessly.”
Earlier this year, Noramco announced that it obtained patents for chemical synthesis of Dronabinol, Cannabidiol, and derivatives in high yield and high stereospecificity. These patents allow production of high-purity, stable synthetic material.
“Pharma companies that choose to work with us in cannabinoids can expect superior quality and secure supplies, starting with a full portfolio of API impurity and reference standards, and continuing with samples, clinical material, and commercial-scale supply from facilities in Europe and the US,” Grubb said.
Dronabinol in sesame oil and ethanol
Noramco maintains a Drug Master File (DMF) for high-purity synthetic Dronabinol API in a solution of 20 per cent sesame oil. The API is produced in Switzerland today via a novel synthesis process, and work is underway to make the product available from Noramco’s US-based production facilities. Going forward, Noramco also will make Dronabinol available in a 20 per cent ethanol solution, with initial synthesis already in progress in Athens, GA. Full GMP material for clinical trials from the US will be available in the first quarter of 2018.
Leveraging eight years of global supply chain expertise in Dronabinol, Noramco is running a global supply programme for Cannabidiol. Included in the programme is a plan to produce high-purity material via a patent-protected synthetic route, utilising assets in the US. Currently, Noramco supplies GMP samples from Europe.