Boosting Pharmaceutical Innovation: Brains Bioceuticals CEP Certification Will Streamline Cannabinoid Drug Development Inspired by Jazz Pharmaceuticals’ CBD-Based Epilepsy Drug and 2024 Sales Forecast of $1.4 Billion
BSPG Laboratories
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 Certification of Suitability (CEP) applications for its active pharmaceutical ingredient (API) cannabidiol (CBD) to the European Directorate for the Quality of Medicines and Healthcare Products (EDQM). This groundbreaking achievement demonstrates that BBC’s CBD meets the highest industry standard for pharmaceutical-grade cannabinoid products.
The CEP confirms that BBC CBD complies with the standards of the European Pharmacopoeia (Ph. Eur.), an important confirmation for pharmaceutical manufacturers in Europe, Canada, Australia, Japan and the USA. This certification simplifies regulatory processes and ensures high quality, consistency and safety for global markets.
Further advantages of the CEP are:
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Facilitating and simplifying interactions between regulators and industry to ensure that substances used in medicines production meet European Pharmacopoeia standards and comply with relevant EU law.
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Simplifying investigational medicinal products management.
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Serves as a complement and bridge between the monographs of the European Pharmacopoeia and the regulatory dossier requirements for medicinal products.
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Acts as a link between health authorities and industry, improving communication and collaboration.
Ricky Brar, CEO and Chairman of the Board of Directors of Brains Bioceutical Corp., emphasized the importance of this certification to the company’s long-term strategy. “Obtaining a CEP for our pharmaceutical ingredient cannabidiol is a critical step in our journey to lead the global cannabinoid market. It underscores our commitment to quality and innovation and positions Brains Bio to set the standard for the industry. This isn’t just about meeting regulatory requirements – it’s about exceeding them and setting a new standard 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 give us a significant competitive advantage and ensure that our cannabidiol API is recognized as a best-in-class ingredient for pharmaceutical use. We are proud to be at the forefront of this rapidly evolving industry and to achieve excellence in every aspect of our business.”
Global demand for cannabinoid-based medicines remains robust, as demonstrated by Epidiolex, which Jazz Pharmaceuticals forecasts will generate sales of approximately $1.4 billion in 2024. (1)This reflects the continued growth and demand for high-quality pharmaceutical cannabinoid products.
The EDQM review process, which will begin on August 8, 2024, will take approximately 115 working days. The successful issuance of a CEP confirms that Brains Bio’s CBD meets the strict requirements of the Ph. Eur.
This CEP application underscores Brains Bio’s unwavering commitment to setting new standards for the cannabinoid industry. This builds on Brains Bio’s EU GMP and Narcotics Licenses. By adapting its CBD API to the strict 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 – a manufacturer of high-quality pharmaceutical-grade cannabinoids – DSM-Firmenich offers an end-to-end innovation platform designed to support early-stage cannabinoid drug development and unlock the potential of CBD-based formulations. Its capabilities include leading formulation expertise, a global network of regulatory specialists, and expertise in preclinical and clinical trials. The company is also able to provide tailored solutions depending on the therapeutic area and drug delivery target. For more information on how DSM-Firmenich’s cannabinoid innovation platform helps improve patient health, please visit: www.dsm.com/cannabinoid-actives.
To Brains Bioceutical Corp.
Brains Bioceutical Is The Leader In evidence-based And scientifically led pioneer from naturally vegetable Health and wellness solutions.
Brains Bio is a leading manufacturer of the highest quality, natural and pure Active Pharmaceutical Ingredients (APIs) and has a unique suite of licenses and registrations. Brains Bio is strategically positioned to leverage the complex regulatory environment to maintain its first-mover and product quality edge. Brains biography Is diversified above The Pharmaceutical, medical, And Nutraceutical Industries within the rapidly growing cannabinoid market, resulting in a strong and unique value proposition.
(1) https://investor.jazzpharma.com/investors
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CONTACT: [email protected] BRAINSBIO.COM 1-855-927-2476
