UK’s Largest EU GMP-Grade Licensed Cannabinoid Research and Commercial Production Facility Opens
Original story from Brains Bioceutical
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Brains Bioceutical, 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.
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.