Valcon Medical achieves milestone: First Danish-manufactured medical cannabis oil approved by the Danish Medicines Agency
Valcon Medical A/S, a Danish medical cannabis manufacturing company, disclosed a significant achievement. The Danish Medicines Agency (DKMA) has approved the inclusion of the first Danish-manufactured medical cannabis oil on the list of authorized medical cannabis products.
COPENHAGEN, DECEMBER 2023 – Valcon Medical A/S, a Danish-based medical cannabis manufacturing company, is pleased to announce that the Danish Medicines Agency (DKMA) has approved the first Danish-manufactured medical cannabis oil to [the list of admitted medical cannabis products]. The product is a 30 mL standardized medical cannabis oil containing 25 mg/mL THC. The product will be marketed via Valcon Medical's wholly-owned subsidiary, Scanleaf ApS.
The approval marks a significant milestone for the Danish healthcare landscape. Scanleaf is the exclusive supplier of Danish-manufactured medical cannabis oil in Denmark. And for Danish patients, who will finally have a locally manufactured medical cannabis oil available at a competitive price.
Specializing in prescription-based medical cannabis products for patient treatment, Scanleaf has experience in importing and distributing products to Danish patients. Scanleaf is now ready to introduce the first Danish-manufactured medical cannabis oil under the name "THC 25 Scanleaf." The product is expected to be available for patients in Q1 2024.
Hasse Herlevsen, CEO of Scanleaf, states: "This approval represents a crucial step in our regulatory work with the DKMA. We are proud to be the first supplier of Danish-manufactured medical cannabis oil under the trial program, confirming our position as pioneers in the European medical cannabis industry."
Valcon Medical (the manufacturer) is committed to a local, sustainable approach. In collaboration with the Danish cultivation company, Schroll Medical ApS, the parties have developed a product adherent to stringent quality standards guaranteed to meet the rigorous requirements set by the Danish Medicines Agency.
"We are thrilled to announce the approval of our first medical cannabis oil in Denmark," said Peter Emil Sigetty, COO at Valcon Medical. "This achievement is a testament to our dedication to quality and focus on a sustainable supply chain. We are proud to contribute to the well-being of patients by providing a locally sourced and manufactured medical cannabis solution."
The advantages of being a Danish-produced product are substantial. The product complies with Danish regulations and quality standards of medicines, ensuring safety and effectiveness. Danish regulations are known for their stringent requirements, guaranteeing patients a reliable and standardized treatment option.
Scanleaf remains dedicated to further research and development in medical cannabis, focusing on expanding its product portfolio to address a wide range of medical conditions. The Company's mission is to improve the quality of life for patients by responsibly harnessing the therapeutic potential of cannabis.
About Valcon Medical A/S:
Based in Denmark and founded in 2018, Valcon Medical is Europe's leading manufacturer of medical cannabis products. The Company is licensed to produce medical cannabis extracts and to manufacture intermediate products under EU GMP standards. The Company's state-of-the-art manufacturing facilities in greater Copenhagen were built to the highest pharmaceutical industry standards. Valcon Medical provides full-spectrum extracts and standardized products, as well as bespoke formulations for the global legal cannabis industry. Valcon Medical uses cutting-edge supercritical CO2 extraction and solvent recovery technologies in its manufacturing process.
Website Valcon Medical
About Scanleaf ApS:
Scanleaf ApS is a leading Danish pharmaceutical company specializing in the distribution of medical cannabis. The approval of Scanleaf's cannabis oil by the DKMA is evidence of the Company's unwavering commitment to quality, innovation, and patient well-being. The Company's cannabis oil is cultivated and produced meticulously in state-of-the-art facilities, adhering to the highest standards of quality and safety. The cannabis product is produced in accordance with Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (GMP) by Valcon Medical A/S, a Danish licensed contract manufacturer of medical cannabis oil.
About Schroll Medical ApS:
Schroll Medical is a Danish-owned company specializing in breeding, cultivating, and manufacturing medicinal cannabis flowers since 2018. Comprising a skilled team of 40 professionals across Denmark and Portugal, the Company has successfully launched its medicinal products in five countries and is poised for further expansion. Demonstrating a commitment to excellence, Schroll Medical ensures that its cannabis flowers are cultivated with the utmost care and in accordance with Good Agricultural and Collection Practice (GACP) for Starting Materials on Herbal Origin and required provisions of the EU-GMP guideline.
Website Schroll Medical
Medical Affairs Manager
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