EUGMP

EUGMP

Brains Bioceutical to provide EU-GMP CBD API for Brazils first medical approved cannabis product

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Brains Bioceutical Corp (“BRAINS” or the “Company”)(Vancouver, Canada), a global leader in pharmaceutical, wellness and veterinary cannabidiol (CBD) based Active Pharmaceutical Ingredient (API) production, is proud to announce its landmark accomplishment to bring Brazil’s first registered medical cannabis product under the new regulations that ANVISA put in place in December of 2019, Brains EU-GMP CBD API to the Brazilian market.

“Our partners in Brazil are a global leader in pharmaceutical production and clinical trials. I’m very proud of this historic moment, wherein we have combined our strengths to create the first registered product under the new regime. The standard we have set for the purity of our CBD is second to none. The team of world-renowned scientists and executives at Brains, continue to achieve landmark milestones with a relentless pursuit of historic firsts in the CBD industry. We look forward to monetizing and capitalizing on the resulting market opportunities that this launch will propel us towards. We now have registered CBD product in the epicenter of the European continent within the UK, and supply the CBD material to our South American partner for achieving the first registered cannabis product under the new ANVIA regulations in Brazil.” said Rick Brar, Chairman and CEO of Brains Bioceutical Corp.

Brains South American partner is a leader in the global pharmaceutical industry. Producing approximately 11.5 billion therapeutic doses per year, and has more than 4,200 employees. The company has one of the largest portfolios of generic drugs in Brazil, and supplies both South American and global markets. Since the recent announcement in December 2019, this is the first registered cannabis product under the special category created by ANVISA. We will be able to export Brains EU-GMP CBD API from the UK for our partner in Brazil to formulate their products to be sold in pharmacies and distributors in Brazil and potentially expand that to the rest of South America as the marketplace expands. All of our partners formulations adhere to the highest quality for manufacturing and testing with a view to making it the safest product available in the region. Under the terms of the agreement, Brains will provide its EU-GMP, CBD API to be used in the registered cannabis products.

“Now more than ever, it is important that patients have access to products that do not compromise on safety and quality. We believe that these products are bringing forward the highest quality product into South America. The Brains industry leading regulatory team was able to introduce the first cannabinoid based specials products in the UK and the first to supply our EU-GMP API ingredient to our partner in Brazil. Brains CBD is one of the few natural, plant-based API ingredients available anywhere on the planet. This team will successfully lead Brains to another first later this year, when we spearhead the reshaping of the CBD industry in the UK by taking the same approach for our Novel Foods application,” added Gurdeep Bains, President of Brains.

Since 2014, Brains subsidiary, BSPG Laboratories, has been a leader in clinical stage, natural source, cannabinoid manufacturing located in Sandwich, Kent, United Kingdom. Brains presently has Medicines and Healthcare Products Regulatory Agency’s (MHRA) approval to manufacture an approved pharmaceutical grade ingredient (API) for the global pharmaceutical industry. Having shipped over 100 kilos to Brazil over the past year, Brains has been providing patients in Brazil with reliable access for over 2 years.

About Brains Bioceutical Corp
Brains Bioceutical Corp is a leader in GMP – certified production of naturally sourced active pharmaceutical ingredients (APIs) for the pharmaceutical and nutraceutical industries. Brains Bioceutical is one of the only natural plant-based cannabinoid active pharmaceutical ingredient (API) manufacturers in commercial production today and is involved in academic and clinical trials across the globe.

Brains Bioceutical Corp. Senior Management Team is made up of a rare hybrid of pharmaceutical and consumer goods executives-having held C-suite and other senior positions with companies such as GW Pharma, Merck, Seattle Seahawks, Golden State Warriors, Danone, Earthbound Farms, International Herbs, Cascadia Specialties and The Royal British Navy. This experience allows Brains to execute at a hyper-efficient level in the pharma and wellness categories.

Brains’ wholly owned subsidiary in the UK, BSPG Laboratories is one of only nine companies that has the commercial capability and EudraGMDP certification to produce CBD API, and is only one of four worldwide to source a natural plant based cannabidiol. Brains is currently manufacturing a line of phytocannabinoid THC-free CBD API products.

MHRA Registered API: Inspected and Registered with the MHRA (Medicines and Healthcare Products Regulatory Agency).

API Certificate Number: UK API 48727

SOURCE: http://www.in.gov.br/web/dou/-/resolucao-re-n-1.186-de-20-de-abril-de-2020-253341253

For further information, please contact:
Calvin Rasode, Director of Marketing
Telephone: 1-855-927-2476
Email: calvin@brainsbio.com
Website: www.brainsbio.com

CAUTIONARY STATEMENT:
This news release contains forward looking statements or forward-looking information (“forward-looking statements”) within the meaning of securities laws. Often, but not always, forward looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. All statements, other than statements of historical fact, in this news release are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance are not statements of historical fact and may be forward-looking statements. Risks, uncertainties and other factors involved with forward-looking statements could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements. Although the Company believes that the assumptions and factors used in preparing the forward-looking statements in this news release are reasonable, there can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws.

 

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