Following inspection by the Dutch Health Care Inspectorate, Bedrocan in the Netherlands has become the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards. This is the first time a medicinal cannabis producer has reached such a high level of compliance. Bedrocan’s production facilities in Canada and the Czech Republic are expected to become fully compliant next year.
GMP is the highest standard a medicine manufacturer must meet in its production process. Bedrocan’s GMP status is a guarantee of the highest quality in both its products and the production process. Tjalling Erkelens, Chairman of Bedrocan International, said: “This is a significant recognition. We have always aimed to meet the highest pharmaceutical standards. Now our way of working is officially recognised by the authorities.”
Since 2003, Bedrocan has produced standardised medicinal cannabis as an active pharmaceutical ingredient (API). It is the only company in the world to produce cannabis flos (the whole, dried flower) with a constant composition of cannabinoids and terpenes. Bedrocan’s Dutch-made medicinal cannabis supplies patients and researchers in the Netherlands, Germany, Finland, Israel, Italy, Macedonia and Poland. In Australia it is used in Australia’s first clinical trial of vaporized cannabis flower bud.
Perry Davidson, CEO and founder of Israel’s Syqe Medical, which incorporates Bedrocan’s medicinal cannabis in its metered-dose inhaler said: “Syqe Medical has developed the world’s first inhaler that delivers medicinal cannabis with the level of precision of traditional medicines. A key factor in our ability to provide a pharmaceutical-grade solution is Bedrocan’s standardised product and uncompromising quality. The GMP compliance achieved by Bedrocan marks a major leap forward for medicinal cannabis, and its acceptance as a mainstream treatment by the medical community.”
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