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CBDepot group gains new EU cGMP certification for Cannabidiol API manufacturing
Teplice, Czech Republic: – Pioneering producer and B2B supplier of upmarket cannabinoid solutions, CBDepot group, has announced EU GMP certification for its new manufacturing site for Cannabidiol (CBD) -based active pharmaceutical ingredients.
On June 22, 2020 the Czech National Competent Authority State Institute for Drug Control issued a Certificate of GMP Compliance of a Manufacturer to CBDepot’s sister company, CB21 Pharma s.r.o.
Synthesized and isolated CBD ingredients
The certification (Certificate number sukls336513/2019) covers the manufacture of Cannabidiol active substances and will be posted in the EudraGMDP register shortly.
CB21 Pharma CEO, Dr. Jan Storch, commented: “This allows CB21 Pharma to bring to the pharmaceutical markets both synthesized and isolated Cannabidiol APIs through exclusive distribution and brokerage arrangements with CBDepot.”
In-house CBD manufacturing
It is now almost three years since CBDepot was introduced at CPhI Worldwide 2017 in Frankfurt as the first company in the EU licensed to produce isolated cGMP CBD via third-party contract manufacturing from Prague. Since summer 2019, the group has been working on relocating its Cannabidiol manufacturing to a new facility in Brno, Cech Republic.
CBDepot Chief Sales Officer Boris Baňas said the GMP certification marked a significant step forward for the group.
“We are extremely excited that our pharma-specific team has managed to deliver the regulatory approval pretty much within deadline, despite the COVID-19 quarantine measures, which have caused three months delay in the auditing process,” said Mr. Baňas.
“Our next two big steps are to submit Active Substance Master Files and implement decarboxylation and distillation processes that will also allow us to provide full-spectrum APIs for various pharmaceutical uses,” he added.
CBDepot is an innovative and recognized producer and B2B supplier of upmarket natural and synthesized cannabinoid ingredients to fast-growing markets in the food, cosmetics, pharmaceuticals and health products industries sectors.
CBDepot specializes in bulk supply of cannabinoid-based ingredients for food, cosmetics and pharmaceutical sectors. Its products ensure that content of tetrahydrocannabinol (THC), the main intoxicating element of cannabis, is below detectable levels. Instead, its products emphasize the two other main natural ingredients, cannabidiol (CBD) and cannabigerol (CBG).
Established in 2014, CBDepot has become a leader in helping to establish legal and quality standards for cannabinoid ingredients and the formulation of cannabidiol derivatives. Since foundation it has operated under legal license granted by the government of the Czech Republic.
The company’s initial mission was the supply of “Legal and Quality CBD” at a time when sourcing ethical and quality isolated CBD was a challenge. CBDepot’s scientific knowledge is based on close links with the Czech Academy of Sciences.
The company’s Chief Sales Officer, Boris Baňas, is an ex-board member of the European Industrial Hemp Association (EIHA), where he successfully campaigned for the establishment of new Europe-wide standards.