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CBDepot and CB21 Pharma: An interview with Michal Tőzsér
For pioneering cannabinoid ingredient specialists CBDepot and sister company CB21 Pharma, 2023 has been a year of far-reaching changes.
The past twelve months have seen CB21 Pharma further extend its EU Good Manufacturing Practice (GMP) certification to produce cannabinoid-based active pharmaceutical ingredients (APIs), such as Cannabis Extractum Raffinatum and Cannabis Extractum Normatum. Meanwhile, CBDepot is transitioning to focus more on HACCP-grade cannabidiol products, with validated novel food applications.
Pharmaceutical-Networking spoke to CBDepot Marketing Director Michal Tőzsér about the changes and road ahead.
Pharmaceutical-Networking: Michal, what are the headline changes that have taken place this year at CBDepot and CB21? Can you sum them up quite briefly?
Michal Tőzsér: There are no headline changes for CBDepot, which carries on and extends our core business of producing high-quality synthesized and isolated CBD and CBG in powder and oily forms.
The main change is that starting from January of 2023, we no longer promote a API portfolio under the CBDepot brand, but rather under the label of our sister company CB21 Pharma, which holds all the EU GMP and narcotic licenses for manufacturing and standardization of Czech-made EU GMP cannabis-derived APIs.
P-N: How did all those changes come about? What are the background factors here?
MT: The focus from non-GMP production, which started in 2015 in CBDepot to GMP portfolio, to a full portfolio of EU GMP cannabis extracts and CBD API and Dronabinol manufactured by sister company CB21 Pharma started back in 2017, when we introduced Europe’s first pharma-grade CBD isolate, under third-party GMP production umbrella and CBDepot marketing umbrella.
We knew from the beginning that contracting out cGMP production to third parties was not sustainable and wanted to bring that capability in house. Furthermore, non-GMP production now has rather limited marketability due to the regulatory landscape.
So our main aim since has been to obtain GMP certification for manufacturing of APIs within our group of companies, in which we have now succeeded.
P-N: What was the relationship between CBDepot and CB21 Pharma before and what is it now? Has anything changed there?
MT: The relationship remains the same. We have remained independent companies within the same JV group. Still, we no longer feel that CBDepot, as a non-pharmaceutical business, remains an appropriate marketing identity and brand for a 100% pharma-oriented company. CB21 Pharma now meets that need.
Meanwhile, CBDepot activities remain in the non-pharma space, such as Novel Foods ingredients and cosmetics.
P-N: How does the leadership of these two companies work? Can you say that one controls or leads the other?
MT: No, that would not be correct. Although both companies are led by our CEO Jan Storch and share some manufacturing capacities and key personnel, including me as Marketing Director and Boris Bañas as Chief Sales Director, these are essentially independent entities that have different corporate strategies and priorities and autonomous control over their own destinies.
P-N: Understood. OK, now let’s look at practical implications of these developments for your customers and partners. How will your product lines and marketing channels change?
MT: Practically, for our partners and customers little changes. All business and customer service-related tasks are handled by Boris Bañas and his team as before.
P-N: Would it be too simple to say that CBDepot is becoming more of a food additive cannabinoid brand, while CB21 has become the label for GMP pharma-grade CBD and other substances?
MT: Yes, that’s a pretty accurate summary. Both companies are B2B cannabinoid ingredient suppliers, with CBDepot being on the non-GMP ingredients side and CB21 Pharma supplying EU GMP certified cannabis-derived APIs.
P-N: Will CBDepot eventually have to become a cGMP producer in its own right?
MT: No, that won’t be necessary, so far as we can see at the moment. CB21 Pharma can cover all the pharma-related manufacture in our group so there should be no need for CBDepot to become a GMP-certified supplier.
P-N: What do you see as the main trends in the ethical cannabinoids sector more generally, particularly in Europe?
MT: The European Food Standards Authority, EFSA, put Novel Food assessments on hold in July 2022. In June 2023 EC issued a consultative call for safety data on use of cannabidiol CBD cosmetics products. So for the moment we see pressures from EU Member States to limit isolated CBD use in both foods and cosmetics. Therefore, use of CBD in consumer products is becoming increasingly limited.
Given the regulatory limitations within Europe, companies are actively exploring markets outside the European jurisdiction. In light of this, our focus has primarily shifted towards the development of an extensive portfolio of APIs based on cannabinoids. CB21 Pharma, for instance, is not only focusing its efforts on API production but is also deeply involved in devising innovative treatments targeting various medical pathologies. Currently, we are engaged in multiple clinical trials intended for label extensions for our existing suppository products, which are officially registered as Class IIa Medical Devices. Additionally, we are navigating through the process of registering a third medical device for dental care applications. Beyond these initiatives, our pipeline includes various other products at different stages of clinical development. So, we have a comprehensive preclinical and clinical development program underway and are enthusiastic about the significant strides we are making in the ethical cannabinoids sector.
P-N: When it comes to events and branding generally, should we now think of CBDepot and CB21 Pharma as sister companies within a ‘CBDepot Group’? Is that how things might be formalized?
MT: Yes, that’s correct.
P-N: Finally, what are your main hopes for the future? What should we expect from both companies?
My hopes for CBDepot are that the company has become a well-established supplier of non-pharma CBD to the UK for the UK FSA validated products under RP70 and RP85 dossier, as well as for cosmetics globally.
As for CB21 Pharma, we want to see the company grow to become a leading brand for the supply of EU GMP cannabis-derived pharma-grade APIs for research and eventually therapeutic use.
I would say all these hopes are well on the way to being fully realized.
P-N: Thank you, Michal.
About CBDepot and CB21 Pharma
Established in 2014, CBDepot has established itself as a pioneering producer and B2B supplier of upmarket cannabinoid solutions, playing a leading role in establishing legal and quality standards for cannabinoid ingredients and the formulation of cannabidiol derivatives.
With its sister company, CB21 Pharma, this Czech group of innovative companies serves fast-growing markets in the food, cosmetics, pharmaceuticals, and health products sectors with high-quality natural and synthesized cannabinoids and cannabis-derived ingredients.
CBDepot’s current strapline “Upmarket Cannabinoid Solutions “reflects its new ability to offer cannabinoid ingredients and substances to various markets such as: cosmetic, food, and food supplements, with Europe-wide recognition as a strong, ethical and transparent supplier of cannabinoids. Meanwhile, CB21 Pharma has become a fully certified pharmaceutical company that manufactures cannabis-derived isolates and extracts to EU GMP standards.
CB21 Pharma is a pharmaceutical company established in autumn 2018. It focuses on developing treatments based on non-psychotropic cannabinoids combined with other active substances and has pioneered innovative medical therapies and functional cosmetics.
The companies share a common heritage and many key personnel, including Chief Sales Officer, Boris Baňas, formerly a board member of the European Industrial Hemp Association (EIHA), where he successfully campaigned for the establishment of new Europe-wide standards. CBDepot’s scientific knowledge is based on close links with the Czech Academy of Sciences.
Learn more at https://www.cbdepot.eu