Cannabidiol (CBD)

Cannabidiol, more commonly known as CBD, is a non-psychoactive compound found in the cannabis plant, valued for its growing therapeutic potential in conditions like epilepsy, pain, and inflammation. CBD works by interacting with the body’s endocannabinoid system, which regulates functions like mood, appetite, and sleep.

Indena’s journey in CBD production began in 2021 with two key authorizations: permission from the Italian Ministry of Health to manufacture cannabinoid-based cannabis extracts, and AIFA’s approval for pharmaceutical-grade CBD. Now, we are proud to announce a second major milestone: Indena is the first global API manufacturer to secure European CEP certification for our pharmaceutical-grade CBD extract.

We use registered varieties of Cannabis sativa with a THC level of less than 0.2%, in accordance with European standards, and guarantee a residual THC content below 0.02%, significantly under FDA and DEA limits. This rigorous approach enabled us to promptly submit a DMF (Drug Master File) for FDA approval.

Our hemp biomass is processed in a pharmaceutical-grade facility authorized by AIFA and inspected by leading international regulatory agencies, including FDA, KFDA, and PMDA. All production adheres to pharmaceutical GMP standards, reflecting over 100 years of Indena’s commitment to the highest quality standards recognized by the global scientific community.