Linneo Health announced that its dried flower facility has been awarded the EU Good Manufacturing Practice (GMP) Part I license by the Spanish Agency of Medicines and Medical Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS) for the manufacturing of intermediates and finished medicinal cannabis products. This new certification greatly extends Linneo's existing Part II license for the manufacture of Active Pharmaceutical Ingredients (APIs).
EU-GMP certification is recognized by all medicine regulatory agencies within the EU, as well as the majority of leading agencies over the world.
This certification also brings additional packaging capabilities for Linneo's dried flower products, allowing Linneo to manufacture in a wide range of formats and sizes tailored to customer needs. Another benefit is that it avoids the need for the local release of dry flowers, so customers do not have to go through the process of analyzing the product locally. "This certification demonstrates Linneo's unrivaled focus on quality and clinical standards."
Don Bellamy, Chief Executive Officer of Linneo Health, said: "I'm delighted to share the news of our GMP Part I certification, which marks a further milestone for Linneo. Obtaining EU GMP Part I certification of our dried flower facilities perfectly complements our existing Part II license. As our customers and their requirements develop, Linneo is perfectly positioned as the supplier of choice to provide high-quality cannabis products tailored to our customers' needs."
Maria José Garcia, Quality and RA Director of Linneo Health, added: "At Linneo, we work continuously to ensure our facilities meet the strictest EU GMP requirements. This certification represents a huge combined effort of the Linneo team. We are excited to be able to provide our customers with an expanded product offering – our excellent cannabis dried flower, APIs, and now finished dosage forms."
For more information:
Linneo Health
[email protected]
linneohealth.com