Advancing Pharmaceutical Innovation: Brains Bioceutical’s CEP Certification will Streamline Cannabinoid Drug Improvement, Impressed by Jazz Prescription drugs’ CBD-Primarily based Epilepsy Drug and 2024 $1.4 Billion Income Projection

Brains Bioceutical Corp. (BBC) has achieved a groundbreaking milestone by submitting one of many world’s first CEP (Certification of Suitability) software for its Cannabidiol (CBD) Lively Pharmaceutical Ingredient (API) to the European Directorate for the High quality of Medicines & Healthcare (EDQM). This landmark achievement demonstrates BBC’s CBD as assembly the very best business normal for pharmaceutical-grade cannabinoid merchandise.

The CEP confirms that BBC’s CBD meets European Pharmacopoeia (Ph. Eur.) requirements, a vital endorsement for pharmaceutical producers in Europe, Canada, Australia, Japan, and the US. This certification streamlines regulatory processes, making certain prime quality, consistency, and security for world markets.

Further benefits of the CEP embody:

• Facilitating and simplifying interactions between regulators and business, making certain that substances utilized in pharmaceutical manufacturing meet European Pharmacopoeia requirements and adjust to related EU laws.
• Easing the administration of investigational medicinal product for medicinal merchandise.
• Serving as a complement and bridge between European Pharmacopoeia monographs and the regulatory file necessities for medicinal merchandise.
• Performing as a hyperlink between well being authorities and business, enhancing communication and cooperation.

Ricky Brar, CEO and Chairman of Brains Bioceutical Corp., emphasised the significance of this certification within the firm’s long-term technique. “Reaching a CEP for our Cannabidiol Lively Pharmaceutical Ingredient is a pivotal step in our journey to guide the worldwide cannabinoid market. It reinforces our dedication to high quality and innovation, and it positions Brains Bio to set the usual for the business. This isn’t nearly assembly regulatory necessities—it’s about exceeding them and setting a brand new benchmark for what pharmaceutical-grade cannabinoid merchandise needs to be.”

Dean Billington, Chief Working Officer of Brains Bioceutical Corp., added, “Our submission to the EDQM is a testomony to the arduous work and dedication of our group. The CEP will present a major aggressive benefit, making certain that our Cannabidiol API is acknowledged as a top-tier ingredient for pharmaceutical use. We’re proud to be on the forefront of this quickly evolving business, driving excellence in each facet of our operations.”

The worldwide demand for cannabinoid-based prescription drugs stays strong, evidenced by Epidiolex, which Jazz Prescription drugs tasks will generate roughly $1.4 billion in income in 2024 ^[1]. This displays ongoing progress and demand for high-quality pharmaceutical cannabinoid merchandise.

The EDQM’s assessment course of, initiated on August 8, 2024, will take roughly 115 working days. Profitable granting of a CEP will affirm that Brains Bio’s CBD meets, the stringent Ph. Eur. necessities.

This CEP software effort underscores Brains Bio’s unwavering dedication to setting new requirements for the cannabinoid business. This builds on Brains Bio’s EU GMP and managed substances licenses. By aligning its CBD API with the rigorous standards of the European Pharmacopoeia, Brains Bio is just not solely collaborating out there however actively shaping its future.

As a part of our strategic partnership, Brains Bioceutical and DSM-Firmenich have joined forces to leverage their mixed experience in cannabinoid analysis and improvement. Along with Brains Bioceutical – producer of high-quality pharma-grade cannabinoids – DSM-Firmenich provides an end-to-end innovation platform designed to help early-stage cannabinoid drug improvement and understand the potential of CBD- primarily based formulations. Its capabilities embody modern formulation experience, a world community of regulatory specialists, and preclinical and scientific examine proficiency. The corporate additionally has the capability to supply custom-made options relying on the therapeutic space and drug supply goal. To study extra about how DSM-Firmenich’s cannabinoid innovation platform helps to raise affected person well being, go to: www.dsm.com/cannabinoid-actives.