Indena has been authorised by the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts. The company will produce pharmaceutical grade cannabidiol (CBD) for clinical and commercial use.
The raw material will be grown and processed in Italy. The supply chain, which complies with the strict criteria set out in the Italian regulations, is controlled, certified and traced by the company. The company says its rigour in managing the production chain was a key factor in obtaining authorisation.
Indena uses registered varieties of hemp with a THC level of less than 0.2% in accordance with European standards. It also guarantees a residual THC content of less than 0.02%, well below the limits defined by the FDA and by DEA. This approach enabled Indena to promptly submit the Drug Master File for this product to the FDA.
"We have been working a long time for this outcome. It is the result of an intense and fruitful collaboration with the Ministry of Health and the AIFA, for the construction of a rigorous approval process to guarantee the safety and control of production, both of the raw material and of the active principle”, said Stefano Togni, Corporate Director for Business Development and Licensing of Indena. “We are aiming at the international pharmaceutical markets. As an Italian company, we are proud to be able to make this totally Italian product of the highest quality available globally, an ingredient expected all over the world for its beneficial effects on a number of pathologies".
The hemp biomass used by Indena is processed in a pharmaceutical plant that is regularly authorised by AIFA and inspected by the main international regulatory agencies (FDA, KFDA, PMDA and others).
CBD is approved for seizures associated with some rare forms of childhood epilepsy (Lennox-Gastaud syndrome, Dravet syndrome and tuberous sclerosis complex), and in clinical development for other forms of epilepsy. It’s also under clinical investigation for schizophrenia, and for its therapeutic potential in other psychiatric disorders, neurological or autoimmune/inflammatory based diseases.
