Indena has received authorization from the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts.
Indena (Milan, Italy) has received authorization from the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts. With this authorization, Indena will produce pharmaceutical-grade cannabinoid (CBD) for the global market for both clinical and commercial use. Indena is the first company in Italy to receive authorization from the Ministry of Health to manufacture cannabinoid-based cannabis extracts.
"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 at Indena SpA, in a press release. “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.”
Indena uses registered varieties of hemp with THC levels less thatn 0.2% in accordance with European standards, which also guarantees compliance with U.S. standards defined by the FDA, and DEA. This has enabled the firm to promptly submit a drug master file for its CBD product to FDA. The hemp biomass used by Indena is processed in a pharmaceutical plant regularly authorized by AIFA and inspected by the main international regulatory agencies, including FDA. All production is in compliance with pharmaceutical good manufacturing practices.