Linneo Health awarded EU Good Manufacturing Practice (GMP) Part I license
Certification further expands existing offering, enabling Linneo Health to manufacture finished dosage forms alongside dried flowers and APIs
Madrid, Spain, 13th September 2022: Linneo Health, a global leader in the research, cultivation and supply of cannabis to improve human health and wellbeing, today announces 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 manufacture 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 recognised 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 unrivalled 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.”
Enquiries:
Linneo Health
Don Bellamy, CEO
Tel: +34 91 700 20 90
Alcaliber
José Antonio de la Puente, CEO
Tel: +34 91 575 46 67
Consilium Strategic Communications
Amber Fennell / David Daley
Linneo@consilium-comms.com
Tel: +44 (0) 20 3709 5700
About Linneo Health
Linneo Health is a global leader in the research, EU-GMP certified manufacture and supply of medicinal cannabis flowers, extracts and products to pharmaceutical partners developing innovative cannabis-based therapies for patients in need. The world’s only vertically integrated medicinal cannabis supplier, no other company has Linneo’s 90-year heritage in the manufacturing, handling and movement of controlled substances. Linneo is optimally positioned to address the needs of its customers through every stage of product development, regulation and handling.
Linneo Health is setting the benchmark for standards and customer service in medicinal cannabis. Through ongoing investment in one of the most advanced quality control laboratories in Europe, and by applying industry-leading cultivation techniques, Linneo is the trusted partner to address the needs of customers today and, with significant expansion capabilities, the demands of tomorrow. With an unrivalled focus on quality and driven by the firm belief that people around the world deserve to be treated with cannabis medicine of the highest standard, Linneo brings cutting edge innovation in medicinal cannabis to partners, to deliver better patient outcomes and improve lives.
www.linneohealth.com
About Alcaliber
Alcaliber is a leading independent supplier of intermediates and active pharmaceutical ingredients (‘API’) to the global pharmaceutical industry. Alcaliber has a 90-year track record of best-in-class industrial operations in a highly regulated market with strong barriers to entry.
Alcaliber is a fully integrated leader in its sector with a state-of-the-art production facilities and a reputation for outstanding quality products resulting in strong, sustainable growth.
www.alcaliber.com