Brains Bioceutical Corp. Enters USD $490 Billion USA Pharmaceutical Market by way of DMF from US FDA
Brains Bioceutical has Received Submission Acceptance for a Drug Master File (DMF) from the FDA for its CBD Active Pharmaceutical Ingredient (API) manufactured by its subsidiary BSPG Laboratories in the United Kingdom
VANCOUVER, BC / ACCESSWIRE / May 25, 2021 / Brains Bioceutical Corp. ("Brains") a global leader and manufacturer of pharmaceutical, wellness, and veterinary cannabidiol (CBD) Active Pharmaceutical Ingredient (API), is proud to announce another landmark accomplishment. Brains has filed a DMF for CBD API and received confirmation of acceptance from the Food and Drug Administration (FDA) in the USA.
The filing of a DMF allows Brains to enter the $490 billion-dollar pharmaceutical industry  within the USA. This is in addition to various clinical trials currently being conducted around the globe using Brains CBD API. This DMF submission facilitates our pharmaceutical partners conducting their clinical trials, positioning Brains as the leading supplier and regulatory partner for CBD research across the globe. Brains is one of the few top tier, plant based, non-GMO, European Good Manufacturing Practise (EUGMP) CBD API suppliers existing in the world. The CBD API in the DMF is manufactured by Brain's EU-GMP approved UK facility, BSPG laboratories. BSPG are registered with the MHRA as an active substance manufacturer. The CBD API is being used for drug development and clinical trials currently being conducted around the globe.
"This achievement cements our reputation as one of the global leaders in plant based pharmaceutical EUGMP CBD API production and distribution. The Brains Senior Management team, led by our Global Chief Operating Officer Dean Billington, continues to achieve key milestones aggressively and effectively in a hyper-growth market across the globe," said Ricky Brar, Chairman & CEO of Brains Bioceutical. "We are uniquely positioned to continue to generate shareholder value and capitalize on supplying an industry with an ingredient in high demand, as well as reach for new direct targets within the pharmaceutical value chain. We are proud to offer researchers in the USA and across the globe a quality, reliable, and safe CBD API with a DMF - a standard met by very few in the industry."
Drug Master Files (DMFs) are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for human use. Once the DMF filing is accepted by the FDA, pharmaceutical companies can reference the DMF when making a regulatory submission.
Brains is one of few companies in the world producing plant based EU-GMP CBD as an API for pharmaceutical applications, research and development, and clinical trials.
The global demand for plant-based, EU-GMP certified cannabinoid APIs continues to soar across the globe as a result of pharmaceutical companies conducting clinical trials to advance the reach of phyto-cannabinoid based medicines.
About Brains Bioceutical Corp.
Brains Bioceutical Corp. is a leader in EU-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, Danone, Earthbound Farms, International Herbs, Cascadia Specialties and The Royal Navy. Brains' wholly owned subsidiary in the UK, BSPG Laboratories is one of only a few companies that has the commercial capability and Eu GMDP certification to produce CBD API and is only one of four companies worldwide to source a natural plant based cannabidiol.
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.
Brains Bioceutical Corp.
Vancouver, BC, Canada
SOURCE: Brains Bioceutical Corp.
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