Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification with the European Directorate for the Quality of Medicines & Healthcare

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.

As part of our strategic partnership, Brains Bioceutical and DSM-Firmenich have joined forces to leverage their combined expertise in cannabinoid research and development. Together with Brains Bioceutical – manufacturer of high-quality pharma-grade cannabinoids – DSM-Firmenich offers an end-to-end innovation platform designed to support early-stage cannabinoid drug development and realize the potential of CBD- based formulations. Its capabilities include leading-edge formulation expertise, a global network of regulatory specialists, and preclinical and clinical study proficiency. The company also has the capacity to provide customized solutions depending on the therapeutic area and drug delivery objective. To learn more about how DSM-Firmenich’s cannabinoid innovation platform is helping to elevate patient health, visit: www.dsm.com/cannabinoid-actives.

AboutBrainsBioceuticalCorp.

BrainsBioceuticalistheleaderinevidence-basedandscience-ledpioneerofnaturalplant-basedhealthand wellness solutions.

Brains Bio is a leading manufacturer of the highest quality natural and pure active pharmaceutical ingredients (APIs), with a unique suite of licenses and registrations, Brains Bio is strategically positioned to take advantage of the complex regulatory environment, securing its first mover and product quality advantage.BrainsBioisdiversifiedacrossthepharmaceutical,medical,andnutraceuticalsectorswithinthe rapidly growing cannabinoid market, resulting in a strong and unique value proposition.

[1] https://investor.jazzpharma.com/investors

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