Brains Bioceutical Corp. (“Brains Bio” or the “Company”), a global leader in natural, GMP-compliant cannabinoid pharmaceutical ingredients, today announced it has been granted a Certificate of Suitability (CEP) for its Cannabidiol (CBD) pharmaceutical ingredient by the European Directorate for the Quality of Medicines & Healthcare (EDQM). The CEP, which will be listed under BSPG Laboratories, its wholly owned subsidiary, on the EDQM CBD CEP register, confirms that Brains Bio’s naturally-derived CBD fully meets European Pharmacopoeia (Ph. Eur.) character, specification, and methodology requirements for use in pharmaceutical development and commercial drug products.
This milestone follows the Company's previously announced CEP application pathway initiated in August 2024, and represents a significant advancement in the regulatory standardisation of cannabinoid-based pharmaceutical ingredients.
What the CEP Means for Drug Development Partners
For pharmaceutical manufacturers advancing cannabinoid-based programs, the CEP functions as a consolidated regulatory anchor. Drug developers may reference it directly within European marketing authorisation applications, materially reducing duplicative ingredient assessments across multiple jurisdictions, simplifying lifecycle management, and accelerating timelines from clinical development through to commercialisation.
The certification centralises regulatory oversight through EDQM, replacing the need for parallel submissions to individual national authorities and delivering the consistency and predictability that serious pharmaceutical programs demand.
This matters most for companies operating in EU-regulated markets where CEP status is frequently a prerequisite in tender and procurement policies. Brains Bio’s naturally-derived ingredient now carries the highest available regulatory certification in the category.
A Platform Built for What Comes Next
The CEP arrives as Brains Bio advances one of the most operationally active cannabinoid drug development platforms in the world. The Company's expanding drug portfolio spans late-stage development programs across glaucoma, opioid use disorder, and epilepsy in the United States, early market access programs targeting Australia and Brazil, and discovery-stage programs exploring next-generation molecular entities. Clinical programs are progressing across multiple jurisdictions, with regulatory submissions and anticipated approvals expected across several assets.
Each of these programs is supported by Brains Bio’s pharmaceutical-grade ingredient supply. The CEP establishes that ingredient as a regulatory-ready reference point across the full scope of EU and Ph. Eur.-aligned markets globally, including the UK, Germany, Latin America, and the MENA region where the Company is actively pursuing registration and early access strategies. For US-aligned programs, Brains Bio’s active FDA Drug Master File provides the equivalent regulatory foundation.
For pharmaceutical and biotech companies building cannabinoid-based drug programs, the practical implication is straightforward: sourcing from Brains Bio means sourcing from the premier naturally-derived CBD supplier whose ingredient is backed by this level of global regulatory standing.
The Industry's Most Complete Credential Portfolio
The CEP adds to what is now the most comprehensive regulatory credential portfolio for a naturally-derived cannabidiol pharmaceutical ingredient: ICH Q7 compliance, an active FDA Drug Master File, EU ASMF, NSF certification, Kosher and Halal certification, MHRA GMP, over 500 commercial batches, and 36-month stability data. These capabilities position Brains Bio to support pharmaceutical partners across the full drug development lifecycle, from early-stage research and clinical programs through to commercial supply at scale.
For manufacturers evaluating sourcing options in EU-regulated and EU-aligned markets, Brains Bio’s naturally-derived ingredient now carries the highest available regulatory certification in the category. The depth and breadth of the Company’s credential stack reduces regulatory execution risk for drug developers and reflects a manufacturing platform built for the long-term demands of global pharmaceutical supply.
"This is what years of building the right way looks like," said Ricky Brar, CEO and chairman of Brains Bioceutical Corp. "Every certification we have earned, and now the CEP, exists because we refused to cut corners when others did. The companies building serious drug portfolios need a partner whose quality credentials are beyond question. That is Brains Bio."
About Brains Bioceutical
Brains Bioceutical (“Brains Bio” or “Brains”) is a diversified cannabinoid life sciences company with a late-stage portfolio spanning pharmaceutical assets targeting central nervous system (CNS) disorders with high unmet needs, proprietary therapies, and advanced technologies. Headquartered in Vancouver with manufacturing operations in the UK, Brains operates one of the world’s only EU-GMP certified facilities capable of producing pharmaceutical-grade cannabinoids — including cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), and cannabigerol (CBG) — at scale. With the recent completion of its state-of-the-art Phase 2 manufacturing facility, Brains Bio is well positioned to meet growing demand as customers advance through clinical development to commercialization. The company serves pharmaceutical, nutraceutical, and veterinary partners worldwide. For more information, visit brainsbioceutical.com.
Media Contact
Calvin Rasode
calvin@brainsbio.com
