On 22 June 2020, the Czech National Competent Authority State Institute for Drug Control issued a GMP compliance certificate to CB21 Pharma, the sister company of CBDepot.
The certificate covers the manufacture of cannabidiol and will be visible in the EudraGMDP system shortly.
CB21 Pharma CEO Dr Jan Storch said: “This allows CB21 Pharma to bring to the pharmaceutical markets both synthesized and isolated cannabidiol APIs through exclusive distribution and brokerage arrangements with CBDepot.”
During the CPhI 2017 in Frankfurt, CBDepot was introduced as the first company in the EU isolated GMP CBD via a third-party contract manufacturer from Prague. Since 2019, the group took on a project of relocation of cannabidiol manufacture to new premises in Brno.
CBDepot CSO Boris Baňas says: “We are extremely excited our pharma-specific team managed to deliver the regulatory approval pretty much within deadline leaving aside the quarantine measures, which have caused a three-month delay in the auditing process. Next two big steps are submitting an Active Substance Master File and implementation of decarboxylation and distillation processes, which will also allow us to provide full-spectrum APIs for various pharmaceutical uses.”