Advancing Pharmaceutical Innovation: Brains Bioceutical's CEP Certification will Streamline Cannabinoid Drug Development, Inspired by Jazz Pharmaceuticals' CBD-Based Epilepsy Drug and 2024 $1.4 Billion Revenue Projection
SANDWICH, United Kingdom, Aug. 22, 2024 (GLOBE NEWSWIRE) -- Brains Bioceutical Corp. (BBC) has achieved a groundbreaking milestone by submitting one of the world's first CEP (Certification of Suitability) application for its Cannabidiol (CBD) Active Pharmaceutical Ingredient (API) to the European Directorate for the Quality of Medicines & Healthcare (EDQM). This landmark achievement demonstrates BBC's CBD as meeting the highest industry standard for pharmaceutical-grade cannabinoid products.
The CEP confirms that BBC's CBD meets European Pharmacopoeia (Ph. Eur.) standards, a crucial endorsement for pharmaceutical manufacturers in Europe, Canada, Australia, Japan, and the US. This certification streamlines regulatory processes, ensuring high quality, consistency, and safety for global markets.
Additional advantages of the CEP include:
- Facilitating and simplifying interactions between regulators and industry, ensuring that substances used in pharmaceutical production meet European Pharmacopoeia standards and comply with relevant EU legislation.
- Easing the management of investigational medicinal product for medicinal products.
- Serving as a complement and bridge between European Pharmacopoeia monographs and the regulatory dossier requirements for medicinal products.
- Acting as a link between health authorities and industry, enhancing communication and cooperation.
Ricky Brar, CEO and Chairman of Brains Bioceutical Corp., emphasized the importance of this certification in the company's long-term strategy. "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 it 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., added, "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 recognized 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."
The global demand for cannabinoid-based pharmaceuticals remains robust, evidenced by Epidiolex, which Jazz Pharmaceuticals projects will generate approximately $1.4 billion in revenue in 2024 [1]. This reflects ongoing growth and demand for high-quality pharmaceutical cannabinoid products.
The EDQM's review process, initiated on August 8, 2024, will take approximately 115 working days. Successful granting of a CEP will confirm that Brains Bio's CBD meets, the stringent Ph. Eur. requirements.
This CEP application effort underscores Brains Bio's unwavering commitment to setting new standards for the cannabinoid industry. This builds on Brains Bio's EU GMP and controlled substances licenses. By aligning its CBD API with the rigorous criteria of the European Pharmacopoeia, Brains Bio is not only participating in the market but actively shaping its future.
