Through its wholly owned subsidiary BSPG Laboratories, Brains Bio’s new facility is set to become a global research center for cannabinoid research, testing, and commercialization of natural EU GMP API’s
September 29, 2022 01:00 ET | Source
VANCOUVER, British Columbia and SANDWICH, United Kingdom, Sept. 29, 2022 (GLOBE NEWSWIRE) — Brains Bioceutical Corp (“Brains” or the “Company”), is pleased to announce the opening of its recently completed EU-GMP cannabinoid manufacturing facility. Brains Bio held a grand opening event for members of the media, investors, researchers, partners, and other stakeholders relevant to the company’s developing position as a leading supplier in the field of EU GMP cannabinoid based Active Pharmaceutical Ingredients Thursday, September 29th, 2022.
The Brains Bio executive team and board welcomed guests and dignitaries from the global pharmaceutical sector, the medical and public health fields, local and national politics, and the business community to celebrate this significant achievement.
“Our company’s commitment to clinical research around efficacy and safety continue to remain the main force behind our team’s commitment and growth,” said Brains Chairperson and CEO, Ricky Brar. “By having one the largest EU GMP grade cannabinoid R&D and commercial facilities, we have positioned Brains Bio to be the number one supplier of safe, natural cannabinoid API’s, our team has set the highest and most stringent production standards in the industry.”
While acknowledging the critical opportunities and gaps in cannabinoid research and data, Brains Bio has undertaken to provide evidence to support the efficacy and safety of cannabinoids in the treatment of major diseases by partnering with numerous organizations and institutions conducting pre-clinical research and clinical trials globally.
Brains Bio’s market-leading position is further enhanced by its regulatory package, which includes:
- An actively maintained EU Active Substance Master File (ASMF).
- A US Drug Master File (DMF) filed with the US Food and Drug Administration (FDA),
- Drug Substance (DS) section of the Investigational Medicinal Product Dossier (IMPD)
- German DAC monograph compliant.
- Drug Product (DP) section of the IMPD available from a third-party partner company
- 36-Month stability data.
- Over 350 commercial batches manufactured with resulting batch consistency and standardization data.
- Approved IND filings with the US FDA.
- Non-GMO, Kosher, Halal
- Tested as being free of THC and banned substances by informed Choice, NSF and INRS (a WADA certified lab)
- NSF certified
Brains Bio’s wholly owned subsidiary BSPG Laboratories, and the subsequent facility expansion provides the infrastructure to become one of the world’s leading cannabinoid API manufacturers. “BSPG is one of very few companies with EU-GMP certification for both human and veterinary use and is registered with the MHRA as an active pharmaceutical ingredient (API) manufacturer for cannabinoids,” said Dean Billington, Global Chief Operating Officer at Brains Bio. “This expanded facility will provide an 8x increase in capacity for the manufacture of CBD and other cannabinoids. With the team, infrastructure and partnerships in place, Brains Bio has quickly become an industry leader in both the nutraceutical and pharmaceutical cannabinoids.”
To date, the current natural EU GMP cannabidiol API being manufactured iby BSPG has been used in over 15 clinical trials, exploring its effects on treating COVID-19, epilepsy, anxiety, insomnia, opioid addiction, and muscle inflammation.
For more information on Brains Bio, please visit www.brainsbioceutical.com.
ABOUT BRAINS BIOCEUTICAL CORP
Brains Bioceutical is the leader in evidence-based Phyto-cannabinoid health solutions to enhance life and treatment options for all. Brains Bio is a leading manufacturer of natural and pure active pharmaceutical ingredients (APIs), with a unique suite of licenses and registrations, Brains Bio is strategically positioned to take advantage of the complex regulatory environment, securing its first-mover and product quality advantage. Brains Bio is diversified across the pharmaceutical, medical, and nutraceutical sectors within the rapidly growing cannabinoid market, resulting in a strong and unique value proposition.
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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