Indena, a leading Italian company in international markets, has been authorised by the Italian Ministry of Health and Italian Medicines Agency ( AIFA ) to produce cannabinoid – based cannabis extracts .Indena will produce pharmaceutical grade cannabidiol (CBD ) for the global market for clinical and commercial use.
” 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 ” , says Stefano Togni, Corporate Director for Business Development and Licensing of Indena SpA . “ 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 , a n 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) . All production is carried out in compliance with pharmaceutical GMP (Good Manufacturing Practices), in line with the highest quality standards that the company has always applied which have been recognised by the international scientific community and consolidated over 100 years of business.
Cannabidiol (CBD) is an active pharmaceutical ingredient whose use 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. Furthermore CBD is under clinical investigation for schizophrenia, and for its therapeutic potential in other psychiatric disorders, neurological or autoimmune/inflammatory based diseases 1.