Milan, Italy—Indena has been authorized by the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts, according to a press release, making Indena the first company in Italy to receive this authorization from the Ministry of Health and one of the only companies in the world able to produce CBD for the pharmaceutical market.
Indena will produce pharmaceutical grade cannabidiol (CBD) for the global market for both clinical and commercial use. The raw material, consisting of registered varieties of hemp with a THC level of less than 0.2%, will be grown and processed in Italy. The low THC level guarantees a residual THC content of less than 0.02%, allowing Indena to submit the Drug Master File for its CBD to FDA. The supply chain is fully traceable; the press release notes that Indena’s historical rigor in managing its production chain was a key factor in obtaining authorization.
“We have been working a long time for this outcome,” said Stefano Togni, Corporate Director for Business Developing and Licensing at Indena, in the press release. “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. 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.”