Netherlands-based Bedrocan International has been recognised as the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards.
The latest news follows an inspection carried out by the Dutch Health Care Inspectorate.
Following the announcement, Bedrocan’s production facilities located in Canada and the Czech Republic are expected to become fully compliant next year.
The company stated that GMP is the highest standard to be met by a medicine manufacturer in its production process.
Bedrocan International chairman Tjalling Erkelens 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.”
The company has produced standardised medicinal cannabis as an active pharmaceutical ingredient (API) since 2003.
It produces cannabis flos (the whole, dried flower) with a constant composition of cannabinoids and terpenes.
Bedrocan’s medicinal cannabis supplies patients and researchers in countries such as the Netherlands, Australia, Germany, Finland, Israel, Italy, Macedonia and Poland.
Israel’s Syqe Medical incorporates Bedrocan’s medicinal cannabis in its metered-dose inhaler.
Syqe Medical CEO and founder Perry Davidson 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.”