The Czech National Competent Authority State Institute for Drug Control issued a CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER to CB21 Pharma sro, the sister company of CBDepot on 22 June.
Certificate number sukls336513 / 2019 will be available within the EudraGMDP system within a few days’ time, covering the manufacture of Cannabidiol Active substance.
Dr Jan Storch, CEO of CB21 Pharma, said: “This allows CB21 Pharma to bring to the pharmaceutical markets both synthesised and isolated Cannabidiol APIs through exclusive distribution and brokerage arrangements with CBDepot.”
In Frankfurt, during the CPhI 2017 event, the company introduced as the first company in the EU isolated GMP CBD via a third-party contract manufacturer from Prague. Since last summer, the group took on a project of relocation to new premises of Brno of Cannabidiol manufacture.
Boris Baňas, CSO of CBDepot, said: “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 three months delay in the auditing process. Next two big steps are submitting 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.”
For more information, please fill out the enquiry form attached to this page.