BOGOTA, Colombia – Clever Leaves, a leading vertically-integrated Colombian licensed producer of pharmaceutical-grade medical cannabis and hemp extracts, has become the first cannabis company authorized by the Colombian National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos or INVIMA) to be Good Manufacturing Practices (GMP) certified to produce medical cannabis. GMP certification by INVIMA allows Clever Leaves to produce phytotherapeutic medicines derived from cannabis which can be prescribed through a medical distribution channel.
“This is a crucial milestone for the medical cannabis industry in Colombia. GMP certification by INVIMA demonstrates that the industry is achieving pharmaceutical-grade standards recognized by regulators throughout the world. This step forward allows us to enhance our positioning as a leading medical cannabis producer and is the result of more than a year of effort, discipline and dedication of a highly qualified work team committed to the health of patients globally,” said Andres Fajardo, CEO of Clever Leaves.
“Obtaining GMP certification from INVIMA underscores Clever Leaves’ competitive advantages and status as an industry leader in the global cannabis market. INVIMA’s GMP certification is formal recognition of Clever Leaves’ operational excellence and adherence to international pharmaceutical standards. In a rapidly-emerging industry where patients and regulators have a lack of internationally-recognizable quality standards on which to rely, GMP certification is a difficult-to-obtain but easy-to-recognize symbol of quality,” said Kyle Detwiler, CEO of Northern Swan Holdings, Inc., the financial sponsor and strategic partner of Clever Leaves.
INVIMA is a regulatory agency within Colombia’s Ministry of Health. INVIMA is responsible for inspecting and supervising the marketing and manufacturing of health products, as well as providing medical approval for the import and export of various products. INVIMA performs many tasks which are akin to functions of the U.S. Food and Drug Administration (FDA). GMP certification from INVIMA is a quality assurance validation system which allows pharmaceutical distribution channels to evaluate the quality and safety of manufactured products and is generally considered to be a prerequisite in the process of obtaining final market authorization in highly regulated markets.
Since its founding in 2016, Clever Leaves has achieved a number of significant milestones which have established Colombia as a future leader of the industry, including the first export of dried flower to Canada for scientific research purposes as well as the first Colombian cannabidiol (“CBD”) product to the United Kingdom, and now GMP certification from a leading pharmaceutical regulatory agency.
About Clever Leaves
Clever Leaves is a vertically-integrated Colombian company which is legally licensed to cultivate and extract medical cannabis and hemp oil. Clever Leaves is currently cultivating over 1.5 million square feet of greenhouses under Good Agricultural and Collection Practices (GACP). The cultivation facilities are expanding to 2.5 million square feet by the end of 2019 with the goal of reaching 10 million square feet by 2021. In addition, the Company obtained its Colombian Good Manufacturing Practices (GMP) certification from INVIMA after inspection of its top-of-the-line extraction facility and is in the process of being certified with European Good Manufacturing Practices (EU GMP). The facility is capable of extracting 24,000 kilograms of dried flower currently with expansion underway to increase extraction capacity to 324,000 kilograms of dried flower per year by early 2020. The Company is already one of the world’s largest hemp and medical cannabis producers with over 450 employees.
About Northern Swan
Northern Swan is a multi-national operator (“MNO”) in the federally legal cannabis industry with an emphasis on ecologically sustainable, low-cost, large-scale cultivation and processing as the cornerstone of building out distribution and brands. Beyond Clever Leaves, Northern Swan is expanding its cultivation and extraction capabilities to Portugal. With headquarters in New York and offices in Toronto, Bogota, Frankfurt, Lisbon, Phoenix and London, Northern Swan invests in and assists emerging cannabis companies.