Indena has received authorization from the Italian Ministry of Health and the Italian Medicines Agency (AIFA) to produce cannabis extracts based on cannabinoids.
Indena (Milan, Italy) has received authorization from the Italian Ministry of Health and the Italian Medicines Agency (AIFA) to produce a cannabis extract based on cannabinoids. With this authorization, Indena will manufacture pharmaceutical grade cannabinoids (CBD) for the global market for clinical and commercial use. Indena is the first company in Italy to receive authorization from the Ministry of Health to produce cannabinoid-based cannabis extracts.
“We have worked a long time on this outcome. This is the result of an intense and fruitful collaboration with the Ministry of Health and AIFA, for the construction of a rigorous approval process to ensure safety and production control, both raw materials and active principles,” said Stefano Togni, director. business development and licensing company in Indena SpA, in a press release. “We are targeting the international pharmaceutical market. As an Italian company, we are proud to be able to make this Italian product of the highest quality available globally, an ingredient that is expected around the world for its beneficial effect on a number of pathology. “
Indena uses registered hemp varieties with a THC level of less than 0.2% according to European standards, which also ensures compliance with US standards set by the FDA, and the DEA. This allows the company to immediately submit drug master files for its CBD products to the FDA. The hemp biomass used by Indena is processed in a pharmaceutical factory which is regularly approved by AIFA and inspected by major international regulatory agencies, including the FDA. All production is in accordance with good pharmaceutical production practice.
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