Wilmington, Delaware-headquartered Noramco produces active pharmaceutical ingredients (APIs) for the pharmaceutical industry.
According to the traditionally opioid API-focused firm, which added cannabinoids to its portfolio in March last year, synthetic production can create ‘ultra-pure’ molecules.
“Robust and reproducible synthetic chemistry assures quality, purity, consistency, and stability,” Noramco’s VP of business development and innovation, Bill Grubb, told us in the lead up to AAPS PharmSci 360.
Grubb’s colleague and Noramco senior principal scientist, Wen Chun Zhang, will compare and contrast Noramco’s cannabinoid production approach to other methods – including those from natural sources – at the event, in a talk entitled, ‘The new era of ultra-pure synthetic cannabinoids’.
The synthetic advantage?
When producing pharmaceutical products, a synthetic approach that generates high-purity material is highly advantageous, according to Grubb.
“A synthetic route means that concerns around residual pesticides, heavy metals from the soil, and a myriad of related substances from extraction are not a concern.
“Using a synthetic approach follows an established regulatory framework – European Directorate for the Quality of Medicines (EDQM), US Food and Drug Administration (FDA), Health Canada, etc. – for bringing a pharmaceutical active ingredient and the corresponding dosage form to market,” we were told.
In addition, expanding manufacturing capacity for synthetic production does not depend on greenhouses, said Grubb: “Pharmaceutically inspected API facilities can be utilised. This approach allows Noramco to produce over 30 cannabinoids today with exacting purity.”
The future of cannabinoids
In June this year, GW Pharmaceuticals’ epilepsy treatment, Epidiolex became the first cannabis-derived drug to receive FDA approval. The Drug Enforcement Agency (DEA) has since classified the drug as ‘Schedule 1’, which is the least restrictive category for controlled substances.
As uptake of cannabis-derived candidates grows among GW Pharmaceuticals’ competitors, Noramco has observed an increased demand for cannabinoid APIs – a trend Grubb told us will continue to increase.
“Research reports by Technavio and the Brightfield group estimates compound annual growth rates (CAGRs) for cannabidiol (CBD) of 24 to 55% in the next five years,” said Grubb.
“The number of pre-clinical, Phase I, and Phase II programmes number in the hundreds. Noramco alone is tracking over 80 indications across more than 20 formulation presentations,” he added.
Earlier this month, Noramco announced the additional commercial-scale capacity of dronabinol (THC) at its Athens, Georgia, US facility – meaning the firm will supply both THC and CBD from sites in the US and Europe.