DEMECAN receives GMP certificate for cannabis production facility
Berlin/Dresden, 25. January 2022 – DEMECAN, the only independent German producer of medicinal cannabis, has been granted a manufacturing license in accordance with §13 AMG (German Medicines Act) and GMP (Good Manufacturing Practice) certification for its production facility near Dresden. The GMP manufacturing license granted by the Saxon state authority allows DEMECAN to produce dried cannabis as medicinal products with immediate effect.
The internationally recognized certification ensures the high quality of medicinal products over the entire manufacturing process. GMP stands for “Good Manufacturing Practice” and means the highest manufacturing standards, which are independently monitored and inspected by pharmaceutical authorities.
Dr. Adrian Fischer, a medical doctor and DEMECAN’s managing director, is pleased: “GMP certification is the strictest standard that manufacturers have to meet, as high quality is expected from pharmaceuticals. The fact that we now hold this certificate in our hands is an extraordinary milestone in DEMECAN’s young history and an important one for the development of the German Cannabis Center in Saxony. As founder and CEO, I am very grateful for the great team with which we managed to pass the inspection only six weeks after the completion of our building. And we have now fully ramped up production capacity. That’s an incredible accomplishment, and we’ll celebrate that appropriately as soon as the Covid situation allows.”
The way is now clear for the first cannabis flowers “Made in Germany”. DEMECAN still plans to deliver the first products to the state cannabis agency and through it to pharmacies in Q1/22. The in-house produced flower will then complement the existing Florestura flower portfolio.
With GMP certification, DEMECAN can now produce its own medicines and test them for efficacy through clinical trials. The research activity is important as there is still prejudice against cannabis in medicine. In order to pave the way for further therapeutic areas and to further reduce the prescription hurdles for patients, further research is therefore needed both nationally and internationally. DEMECAN supports this and plans to start its own study this year.
DEMECAN is the only independent German company that covers the entire production chain for medical cannabis – from cultivation, processing, and storage to distribution to pharmacies. The company was founded in 2017 by Dr. Adrian Fischer, Dr. Cornelius Maurer and Dr. Constantin von der Groeben with the aim of guaranteeing patients access to medical cannabis with “Made in Germany” quality. The Federal Institute for Drugs and Medical Devices (BfArM) awarded DEMECAN the contract to grow and process medical cannabis in May 2019. Cultivation and further processing are carried out in accordance with the highest pharmaceutical standards at the facility near Dresden. As a pharmaceutical wholesaler, DEMECAN cooperates with cannabis producers worldwide and imports medical cannabis that meets its own high-quality standards. The DEMECAN Group is a member of the Federal Association of pharmaceutical Cannabinoid Companies (BPC) and a supporting member of the Association of Cannabis Supplying Pharmacies (VCA e.V.).