NEW YORK – Clever Leaves (the “Company”), a leading multi-national operator (MNO) and licensed producer of pharmaceutical-grade medical cannabis and hemp extracts, has been granted European Union Good Manufacturing Practices (EU GMP) certification by the Croatian Agency for Medicinal Products and Medical Devices (HALMED) for its pharmaceutical post-harvest facility and laboratory located outside Bogota, Colombia, to produce Active Pharmaceutical Ingredients (API), semi-finished and finished cannabis products for medical purposes.
The certification recognizes that Clever Leaves’ production facilities comply with quality standards and production guidelines required by the EU for the manufacturing of cannabis and hemp-based pharmaceutical products. EU GMP certification is generally required to import medical cannabis products into the European Union and is expected to broaden Clever Leaves’ ability to serve international markets.
“EU GMP certification greatly expands Clever Leaves’ ability to serve the burgeoning European medical cannabis and hemp markets, which have very strict quality, compliance and regulatory requirements. EU GMP certification expands an early mover advantage for Clever Leaves in the pharmaceutical channel as global demand increases and more legal cannabis geographies emerge,” said Kyle Detwiler, CEO of Clever Leaves.
“As the first company in Latin America and one of a few medical cannabis companies in the world with EU GMP certification, this is a major accomplishment for our operations, regulatory, and quality control teams, and speaks to our commitment to provide our clients and patients with high quality and consistent, pharmaceutical grade products,” said Andres Fajardo, President of Clever Leaves.
Clever Leaves is a global leader in low-cost, high quality and large-scale cannabinoid production. The Company is one of the world’s largest medical cannabis operations in terms of capacity, boasting 1.8 million sq. ft of current cultivation capacity in Colombia and 108,000 kg/year of extraction capacity as well as a pre-licensed cultivation operation in Portugal. Clever Leaves is also pleased to announce that to date the Company has exported products to Australia, Brazil, Canada, Germany, Great Britain, Poland and the United States, among others.
Clever Leaves has achieved several significant milestones including becoming the first and only Colombian cannabis company to be GMP certified by INVIMA, the Colombian food and drug agency, as well as the first to receive Good Agricultural and Collecting Practices (GACP) certification in the Americas by the Control Union´s Medical Cannabis Standard (CUMCS).
About Clever Leaves
Clever Leaves is a multi-national cannabis company with a mission to operate in compliance with federal and state laws and with an emphasis on ecologically sustainable, large-scale cultivation and processing as the cornerstones of its global cannabis business. Clever Leaves is a leading vertically integrated producer of medical cannabis and hemp extracts and is currently cultivating over 1.8 million square feet of greenhouses under Good Agricultural and Collection Practices (GACP) in Colombia. Clever Leaves’ Colombian operation maintains European Union Good Manufacturing Practices (EU GMP) certification as well as Good Manufacturing Practices certification from INVIMA, Colombia’s food and drug regulatory agency. Clever Leaves’ first extraction facility is currently capable of extracting more than 100.000 kilograms of dried flower per year. In November 2019, Clever Leaves received a pre-license notice and authorization from INFARMED I.P., the Portuguese pharmaceutical regulatory authority, to start preliminary cultivation operations for R&D purposes in Portugal. Based on this authorization, Clever Leaves Portugal was able to cultivate medicinal cannabis for research and development purposes on its 85-hectare farm. Clever Leaves is one of the world’s largest hemp and medical cannabis producers, with a global footprint encompassing brands, extraction facilities, cultivation operations and other investments across Canada, Colombia, Germany, Portugal, and the United States.