Brains API – Brains Bioceutical

APIs and Ingredients

Supply of cannabinoid APIs and products to meet customer needs across clinical development and commercialization of authorized pharmaceutical products – ensuring flexibility, scalability, and global reach

High Quality APIs, including our CBD API

Brains Bio’s natural, hemp-derived CBD API – manufactured to EU-GMP standards with a unique suite of licenses and registrations, and used as the active ingredient in 30+ third-party pre-clinical and clinical studies worldwide.

• EU GMP CBD API (98.0–102.0%)
• ICH-Q7 compliant impurity profile < 0.15%
• THC below the limit of detection of 0.000006%
• 36-month retest date
• Fully defined API specification
• Data supporting product consistency from >500 commercial scale batches with negligible variation and within required specification
• Non-genetically modified (Non-GMO) organism
• Halal
• Kosher

Technical Packages

• Data packages including US DMFs, CEP, EU ASMFs and IMPD documentation
• CEP certification granted
• Drug Substance (DS) section investigational medicinal product dossier (IMPD)
• Drug Product (DP) section IMPD available for different dosage forms via commercial partner
• Regulatory approvals: FDA IND in effect for PK study; MHRA CT approval for PK study; TGA approvals for two human proof-of-concept studies; ANVISA Phase III clinical trial authorisation

Cannabinoid Portfolio

A robust portfolio of cannabinoid APIs, ingredients, applications and finished products serving pharmaceutical, nutraceutical and veterinary markets worldwide.

APIs
• CBD API solid
• D9-THC API solid
• CBN API solid
• CBG API solid

Nutraceutical Ingredients
• Nutra CBD isolate solid
• Ph. Eur. CBD isolate solid
• Nutra CBG isolate solid
• Nutra CBDA isolate solid
• Nutra CBDV isolate solid

Drug Intermediates
• Lipid based
• Cyclodextrin based
• Amorphous dispersions

Finished Products
Medical portfolio: CBD oil, CBD capsules (50 mg, 100 mg, 200 mg, 400 mg)
Nutra portfolio: CBD oils, capsules and gummies; CBD creams, gels and serums

Industry and KOL Validation

“Active Pharmaceutical Ingredient (API) by Brains Bioceutical Corp marks a transformative moment in the field of cannabinoid science and pharmaceutical innovation. As a researcher and consultant deeply engaged in the exploration and application of cannabinoid-based therapies, I recognize the profound implications of this advancement for clinical research and the development of new treatments.”

– Dr. Jose Crippa, Professor in Psychiatry and Neurosciences at University of Sao Paulo. Research Leader in the Cannabinoid Field, awarded by the International Association of Cannabinoid Medicines (IACM) for a major contribution to Cannabinoid Research in 2019.

A Foundation for Growth

First-mover pathways (UK/EU/AU/BR) and clinical programs support revenue growth opportunities

Regulatory infrastructure (EU-GMP, DMFs/ASMFs, Home Office Schedule 1, IMPDs and CT approvals) speeds partner onboarding and market access

View the facility tour

Jas Kalsi

An experienced Chartered Professional Accountant with over 30 years of experience in providing personal and corporate taxation, corporate restructuring, financing, public offering and human resources management services. Kalsi is the Chief Financial Officer for Brains Bioceutical Corp., a global manufacturer of naturally-sourced active pharmaceutical ingredients (APIs). In this role, Kalsi is responsible for overseeing and managing the fiscal health of the group, implementing best practices with respect to finance, accounting and internal controls, obtaining funding, providing recommendations on mergers and acquisitions and working collaboratively with the CEO and Board of Directors on strategy. In addition, Kalsi will be responsible to regulatory entities and authorities, including any security exchange commissions.

Kalsi was an audit partner at KPMG focusing on small, medium and large private, government sector and public audit clients. He was the Human Resource Manager in charge of recruiting, staff development and training, and a member of KPMG’s Professional Practice Group. Subsequent to KPMG, Kalsi was the Chief Financial Officer / Chief Executive Officer of a variety of private companies including 6.5 years with a pharmaceutical fulfillment provider and API developer.

Kalsi has a proven track record in hiring top-level senior executives, restructuring companies to minimize tax and maximize cash flows, raising financing and creating a cohesive culture.

Kalsi has a passion for wellness and has created several initiatives and partnered with several leading-edge individuals to help people create and enjoy the best versions of themselves. He sees the use cannabinoids as a major tool to facilitate one’s optimum lifestyle.

With the team and infrastructure in place, Brains Bioceutical has quickly become an industry leader in both the nutraceutical and pharmaceutical cannabinoid industries, with several clinical trials and academic studies underway evaluating the efficacy of cannabinoids to treat major diseases. Under Kalsi’s leadership, Brains Bioceutical has already established market dominance, as it is the only company in the world to sell bulk API commercially around the world, supporting both the pharmaceutical and wellness sectors. With ambitious plans to expand Brains Bioceutical into a global biotech company specializing in cannabinoid health and wellness solutions, Kalsi is pioneering a new frontier in medicinal and wellness solutions across the world.

APIs and Ingredients

Supply of cannabinoid APIs and products to meet customer needs across clinical development and commercialization of authorized pharmaceutical products – ensuring flexibility, scalability, and global reach

High Quality APIs, including our CBD API

Technical Packages

Cannabinoid Portfolio

Industry and KOL Validation

A Foundation for Growth

View the facility tour

Contact Us

General Inquiries:

APIs and Ingredients

Supply of cannabinoid APIs and products to meet customer needs across clinical development and commercialization of authorized pharmaceutical products – ensuring flexibility, scalability, and global reach

High Quality APIs, including our CBD API

Technical Packages

Cannabinoid Portfolio

Industry and KOL Validation

A Foundation for Growth

View the facility tour

Contact Us

General Inquiries:

Jas Kalsi

Chief Financial Officer

Jennifer Archibald

Chief Financial Officer

Barinder Bhullar

Senior Vice President, Corporate Affairs

William Purves

Chief Commercial Officer

Gurdeep Bains

VP of Business Development

Jorja’s Story

A father’s journey to saving his daughter’s life

Dr. Mike Bowen

Dr. Jack Taunton

Dr. Sharon Gurm

Dr. David Putrino

Dr. Gerry Ramogida

Norma Sebestyen

Dean Billington

COO

Terry O’Regan

President

Rick Brar

CEO and Chairman