Mike Montemarano, Associate Editor 03.01.21
Indena, a leading Italian natural products supplier to international markets, is the first company authorized by the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts. Primarily, it will produce pharmaceutical grade cannabidiol (CBD), which it will provide to the global market for clinical and commercial use.
Indena was the first company to receive this authorization from the Ministry of Health, followed by authorization from AIFA, making it one of the few companies in the world that could produce CBD for pharmaceutical applications. CBD is an active ingredient obtained by extraction and isolation from the inflorescences and aerial parts of hemp (Cannabis sativa L.).
With over 100 eyars of experience in producing high-end botanical extracts, Indena reports that it is well-placed to produce high-purity CBD from raw material which will be grown and processed in Italy. The supply chain, which will adhere to Italian regulations, is controlled, certified, and fully traced by the company, and Indena reports that its approach to production management was a key factor in obtaining authorization.
Indena will use registered varieties of hemp with a THC level of less than 0.2% in accordance with European standards, guaranteeing a residual THC content of less than 0.02%, well below the legal limits defined by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This approach enabled Indena to promptly submit the DMF (Drug Master File) for this product to the FDA.
“We have been working a long time for this outcome. It is the result of 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,” Stefano Togni, corporate director for business development and licensing of Indena SpA, said. “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 authorized 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 Indena’s quality standards which the company has always applied.
As a pharmaceutical ingredient, CBD’s use is approved for seizures associated with some rare forms of childhood epilepsy, such as Lennox-Gastaud syndrome, Dravet syndrome, and tuberous sclerosis complex, and it is in clinical development for other forms of epilepsy. CBD is also under investigation for schizophrenia, and for its therapeutic potential in other psychiatric disorders, as well as neurological or autoimmune/inflammatory diseases.
Indena was the first company to receive this authorization from the Ministry of Health, followed by authorization from AIFA, making it one of the few companies in the world that could produce CBD for pharmaceutical applications. CBD is an active ingredient obtained by extraction and isolation from the inflorescences and aerial parts of hemp (Cannabis sativa L.).
With over 100 eyars of experience in producing high-end botanical extracts, Indena reports that it is well-placed to produce high-purity CBD from raw material which will be grown and processed in Italy. The supply chain, which will adhere to Italian regulations, is controlled, certified, and fully traced by the company, and Indena reports that its approach to production management was a key factor in obtaining authorization.
Indena will use registered varieties of hemp with a THC level of less than 0.2% in accordance with European standards, guaranteeing a residual THC content of less than 0.02%, well below the legal limits defined by the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA). This approach enabled Indena to promptly submit the DMF (Drug Master File) for this product to the FDA.
“We have been working a long time for this outcome. It is the result of 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,” Stefano Togni, corporate director for business development and licensing of Indena SpA, said. “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 authorized 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 Indena’s quality standards which the company has always applied.
As a pharmaceutical ingredient, CBD’s use is approved for seizures associated with some rare forms of childhood epilepsy, such as Lennox-Gastaud syndrome, Dravet syndrome, and tuberous sclerosis complex, and it is in clinical development for other forms of epilepsy. CBD is also under investigation for schizophrenia, and for its therapeutic potential in other psychiatric disorders, as well as neurological or autoimmune/inflammatory diseases.
