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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
The medical cannabis producer has become compliant with EMA’s GMP standards.
Bedrocan, a producer of medical cannabis as an active pharmaceutical ingredient, announced on Jan. 23, 2017 that its Netherlands facility has become compliant with EMA’s good manufacturing practice (GMP) standards. In a press statement, the company said it was the first GMP-approved medical cannabis producer.
The company’s Dutch facility produces five strains of pharmaceutical-grade cannabis including Bedrocan, Bedrobinol, Bediol, Bedica, and Bedrolite. In an emailed statement to BioPharm International, Femke Starrenburg, business developer at Bedrocan said, “each strain is standardized according to pharmaceutical standards with a defined active ingredient composition.”
The company said its facilities in Canada and the Czech Republic are expected to become fully EMA GMP compliant next year. Starrenburg said the next step for the company is to become fully FDA compliant, but that Bedrocan’s first priority is its Dutch facilities. The company did not give an expected deadline for FDA GMP compliance. Bedrocan’s medical cannabis is supplied to patients and researchers in the Netherlands, Germany, Finland, Israel, Italy, Macedonia, and Poland.