Linnea SA has been a pioneer in the Cannabinoid active pharmaceutical ingredient (API) industry since it began producing CBD extracts in 2016.
The company’s commitment to absolute Swiss quality, rigorous working methods and compliance with internationally recognized standards has been a signature of all its products, making the Linnea name synonymous with leadership and reliability. A CEP application for its Cannabidiol (CBD) API was therefore of absolute importance, submitted in October 2024, not only guaranteeing its pharmaceutical customers the highest level of quality assurance there is, but also demonstrating the company’s leadership in the industry. In fact, Linnea is one of the first companies in the world to have submitted a CEP application for a Cannabidiol ingredient, setting the bar for quality and compliance in medical Cannabinoids.
What is a CEP?
A Certification of Suitability (CEP) attests to the conformity of a specific API with the standards presented in the monograph of the European Pharmacopoeia (EP). When applying, the manufacturer of the API provides evidence that the quality of their ingredient is in accordance with the EP monograph and, if approved, certification is granted by the European Directorate for the Quality of Medicines (EDQM). A CEP is essential to all manufacturers and suppliers that wish to sell their APIs in Europe, and it promotes trust in the supplier and ingredient among healthcare professionals and the general public. Moreover, it simplifies and speeds up regulatory and administrative processes in the countries where it’s recognized.
Linnea Cannabinoid API milestones
Linnea has been at the forefront of the industry since the launch of its NioSkin® line of cosmetic ingredients in 2015. In 2016, Linnea obtained GMP certification for its CBD extracts, followed by GMP certification for its CBD isolates in 2017. In 2021, Linnea’s Cannabigerol CBG extracts were also given GMP certification. Moreover, the company’s Novel Food application for its CBD extracts and isolates is pending approval by the FSA and EFSA.
This year, in October 2024, Linnea set a new milestone with its submission of a CEP application for its Cannabidiol (CBD) API, one of the first companies in the world to do so. It is just the latest action which attests to the company’s drive to adhere to the highest global standards for all its ingredients, including Good Manufacturing Practices (GMP), Good Agricultural and Collection Practices (GACP) and Hazard Analysis and Critical Control Points (HACCP).
> Learn more about Linnea’s commitment to your business
Cannabinoids: a complex global market
In recent years, there has been marked interest by consumers in the potential benefits of Cannabinoid-based extracts and isolates, leading to growing demand in such APIs in the pharmaceutical, cosmetic and nutraceutical industries. However, the current global cannabinoid market is a quickly evolving and disjointed landscape, with drastic regulatory differences between one country and the next. For example, in Italy, Cannabinoid extracts are categorized as medicines only if they are registered with the European Medicines Agency (EMA), and CBD isolates are considered medical products because CBD is an official API in the European Pharmacopoeia, and such products are only available via doctor’s prescription. As a consequence, producing them requires GMP and CEP certifications. On the other side of the spectrum, Germany allows the free circulation of products containing CBD, though the lack of regulation has resulted in many products which also contain THC or, alternatively, do not contain a reliable, consistent percentage of CBD. As such, GMP and CEP certification can create advantageous positioning in more open markets such as Germany’s.
In such a fractured market, certifications which guarantee quality, precise percentages of active ingredients (and the lack of unwanted substances), and ethical cultivation practices are paramount. With GMP certification for products under the Linnea® Cannabinoids line, and now a pending CEP application for CBD, Linnea is a key supplier of phytochemical APIs to pharmaceutical, nutraceutical and cosmetic B2B customers, providing the exact active ingredients—and guarantees—they need.
Quality and innovation
Linnea’s mission is to research and provide the highest quality botanical ingredients in the world, which it has done since it began producing Vinpocetine, Vincamine and Ginkgo Biloba in Riazzino, Ticino, Switzerland in 1982. And quality is produced through a focus on science, research, standardized controls and sustainability: the core values of Linnea. Each year, Linnea participates in pre-clinical and clinical studies and industry events, interacting with the scientific community to share knowledge about the potential therapeutic benefits of its ingredients and gaining inspiration for future uses of its APIs.
The Linnea approach to cannabinoids is no exception. Whether an extract, isolate or bulk dilution, Linnea’s CBD and CBG ingredients have been meticulously tested, proving their purity. And as it moves forward, Linnea will continue to lead the medical cannabinoid industry through sustainable and compliant solutions, including through its THC-based pharma-grade ingredients.
CEP benefits for stakeholders
CEPs and other certifications have multiple benefits for Linnea’s B2B customers. Pharmaceutical companies that purchase Linnea’s active ingredients can count on a reliable, regulatory-compliant supply chain, which speeds up any necessary approvals for the sale of final products destined for use among the public. In fact, CEPs are accepted by the 39 signatory states of the European Pharmacopoeia and a few other countries outside the EU, such as Australia, Canada, South Africa, and Saudi Arabia, opening the doors to product commercialization worldwide. Likewise, regulators will benefit from a simplification of compliance assessments and verifications, giving rise to greater efficiency. And the industry as a whole gains trust thanks to the benchmarks established for the quality of Cannabinoid APIs.
Conclusion
Linnea’s Cannabidiol API CEP application is a concrete demonstration of its commitment to quality, the latest in the company’s long list of compliance certifications. Such adherence to strict guidelines and best practices, a guarantee of rigorous testing of its active pharmaceutical ingredients, reinforces Linnea’s role as a dependable partner and pioneer in the Cannabinoid API market, today and tomorrow.
Want to learn more?
> Watch the video interview with Emanuela Torrisi, Linnea’s Chief Regulatory Officer
> Explore Linnea’s Cannabinoid portfolio
> Get in touch with our team of experts to learn more about Linnea’s high-quality Cannabinoid APIs: [email protected]