In a significant development for the pharmaceutical cannabinoid industry, Brains Bioceutical Corp. (BBC) has submitted one of the world’s first Certification of Suitability (CEP) applications for its Cannabidiol (CBD) Active Pharmaceutical Ingredient (API) to the European Directorate for the Quality of Medicines & Healthcare (EDQM). This pioneering move marks a key milestone in BBC’s mission to set the standard for pharmaceutical-grade cannabinoid products on a global scale.
The CEP certification, if granted, will affirm that BBC’s CBD meets the rigorous standards of the European Pharmacopoeia (Ph. Eur.), a critical benchmark for pharmaceutical manufacturers operating in Europe, Canada, Australia, Japan, and the United States. This certification plays a vital role in simplifying regulatory processes, ensuring the consistency, quality, and safety of cannabinoid-based products across these international markets.
Streamlining Global Standards
The advantages of obtaining a CEP are manifold. It not only streamlines the regulatory interactions between industry players and authorities but also ensures that substances used in pharmaceutical production comply with European Pharmacopoeia standards and EU legislation. This certification also simplifies the management of investigational medicinal products and acts as a crucial bridge between European Pharmacopoeia monographs and the regulatory dossier requirements for medicinal products.
Moreover, the CEP enhances communication and cooperation between health authorities and the pharmaceutical industry, serving as a key link that facilitates the development and distribution of high-quality medicinal products.
Leadership in the Cannabinoid Industry
Ricky Brar, CEO and Chairman of Brains Bioceutical Corp., underscored the strategic importance of this certification for the company. “Achieving a CEP for our Cannabidiol Active Pharmaceutical Ingredient is a pivotal step in our journey to lead the global cannabinoid market. It reinforces our commitment to quality and innovation and positions Brains Bio to set the standard for the industry. This is not just about meeting regulatory requirements—it’s about exceeding them and setting a new benchmark for what pharmaceutical-grade cannabinoid products should be.”
Dean Billington, Chief Operating Officer of Brains Bioceutical Corp., highlighted the competitive edge that the CEP would provide. “Our submission to the EDQM is a testament to the hard work and dedication of our team. The CEP will provide a significant competitive advantage, ensuring that our Cannabidiol API is recognised as a top-tier ingredient for pharmaceutical use. We are proud to be at the forefront of this rapidly evolving industry, driving excellence in every aspect of our operations.”
Growing Demand for Cannabinoid Pharmaceuticals
The global demand for pharmaceutical cannabinoid products continues to rise, as evidenced by the success of Epidiolex, a cannabinoid-based medication that Jazz Pharmaceuticals projects will generate approximately $1.4 billion in revenue in 2024. This ongoing growth underscores the importance of high-quality, pharmaceutical-grade cannabinoid products in the global market.
The EDQM’s review of Brains Bio’s CEP application began on 8 August 2024 and is expected to take approximately 115 working days. A successful outcome would confirm that Brains Bio’s CBD API meets the stringent requirements set forth by the European Pharmacopoeia, further solidifying the company’s position as a leader in the cannabinoid industry.
Strategic Partnerships and Innovation
Brains Bioceutical’s submission is part of its broader strategy to set new standards in the cannabinoid sector, building on its existing EU GMP and controlled substances licences. The company is also leveraging strategic partnerships to enhance its research and development capabilities.
In collaboration with DSM-Firmenich, a global leader in cannabinoid innovation, Brains Bioceutical is working to advance early-stage cannabinoid drug development. This partnership combines Brains Bio’s expertise in manufacturing high-quality pharma-grade cannabinoids with DSM-Firmenich’s cutting-edge formulation capabilities, global regulatory network, and proficiency in preclinical and clinical studies. Together, they aim to deliver customised solutions tailored to specific therapeutic areas and drug delivery objectives, ultimately elevating patient health through innovative CBD-based formulations.
As Brains Bioceutical continues to shape the future of the cannabinoid industry, this CEP application represents a critical step in ensuring that their products not only meet but exceed the highest standards of pharmaceutical quality and safety.