GMP production of CBDepot group Cannabidiol as a pharma API

products-servicesCBDepot s.r.o.

May 28th 2021

CBDepot has underlined its status at Europe’s leading manufacturer of ethical hemp-derived and cannabinoid-related products by fully certificating its Czech Republic production facilities for isolated and synthesized Cannabidiol (CBD) as an active pharmaceutical ingredients to full EU Good Manufacturing Practice (GMP) standards.

GMP certified status is confirmed by the Czech National Competent Authority State Institute for Drug Control, which has issued a Manufacturer Certificate of GMP Compliance to CBDepot sister company CB21 Pharma, for its plant in Brno that specializes in production of trans-cannabidiol (trans-CBD) as an active substance. The certification has been filed with the EU’s EudraGMDP system.

In-house GMP production

The certification allows CB21 Pharma to offer the pharmaceutical markets both synthesized and isolated Cannabidiol APIs through exclusive distribution and brokerage arrangements with CBDepot.

Since 2017, CBDepot has been offering isolated GMP CBD via third party contract manufacturing arrangement but has now brought production fully in-house from its new facility in Brno.

The facility uses chemical synthesis to manufacture pharma grade synthesized (–)-trans-Cannabidiolum as well as isolating pure CBD distillate from cannabis sativa plants. Both are suitable as cGMP active substance for pharmaceutical use.

Upgraded processes

CBDepot is also submitting an Active Substance Master File and is implementing decarboxylation and distillation processes that will enable manufacture of full-spectrum GMP standard cannabinoid APIs for various pharmaceutical uses.

CBDepot has released a full presentation from its Chief Sales Officer Boris Baňas explaining more about the legal status of cannabinoids in products for the EU market (see Resources).