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Linneo Health receives EU-GMP Part I licence

Linneo Health has been awarded an EU Good Manufacturing Practice (GMP) Part I licence, further expanding its existing offering.

The company’s dried flower facility has been awarded the licence by the Spanish Agency of Medicines and Medical Products (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS).

The licence pertains to the manufacture of intermediates and finished medicinal cannabis products, and its receipt extends Linneo’s existing Part II licence for the manufacture of Active Pharmaceutical Ingredients (APIs).

Linneo Health CEO, Don Bellamy, 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 licence.

Read more: Linneo Health explores trends in medical cannabis

“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.”

This certification brings additional packaging capabilities for Linneo’s dried flower products, allowing the company to manufacture in a wide range of formats and sizes, and also avoids the need for the local release of dry flowers, meaning customers do not have to go through the process of analysing the product locally. 

Read more: Gerardo Gorostiza joins team at Linneo Health

Quality and RA director of Linneo Health, Maria José Garcia, 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.”

The company also recently announced an expanded medicinal cannabis offering to include industrial cannabis derivatives. The offering is the result of an exclusive CDMO agreement with Alcaliber, adding the capabilities to supply APIs and medicinal finished dosage forms, such as THC and standardised cannabis extracts.

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