LEDUC, Alberta, February 13, 2023 – PBG BioPharma Inc. (PBG) is pleased to announce that it has successfully filed a master drug file (MDF) on a Cannabinoids-based pharmaceutical drug with Health Canada. The filing of the MDF is a major milestone for PBG, as it will enable the company to move forward with its drug development program.
The MDF filing is a critical step in the drug development process, as it provides the necessary documentation for Health Canada to review and approve the company’s cannabinoids-based drug products for clinical trials and eventual market access. The MDF includes detailed information about the drug product, its ingredients, manufacturing process, and quality control measures.
“We are thrilled to have achieved this important milestone,” said PBG CEO, Dr. Jacqueline J. Shan. “We are now one step closer to bringing our innovative cannabinoids-based drug products to market and allows for collaboration with biopharmaceutical organizations and medical research institutions interested in commercialization and/or conducting clinical research on the potential therapeutic uses of our pharmaceutical APIs and drug products.”
PBG BioPharma Inc. is a vertically integrated biopharmaceutical company focusing on the research, development, and manufacturing of biopharmaceuticals and nutraceuticals. The Company takes a pharmaceutical approach to its product development, testing and manufacturing process for premium quality, pharmaceutical grade ingredients and formulations. PBG has constructed a 25,000 square foot state-of-the-art, GMP standard biopharmaceutical production and lab facility, and amassed a large licence portfolio, including a Cannabis Standard Processing Licence with Sale Amendment Licence, Medical Cannabis Sales License, a Cannabis Analytical Licence, 4 Cannabis Research Licences including an Institutional Wide Research Licence, GMP NHP Site Licence, Controlled Drug and Substances Dealer’s Licence, and ISO 17025 certification, which will allow the company to provide point-to-point business from clinical research to product development/testing and manufacturing. PBG is currently conducting research and therapeutic development in the areas of broad-spectrum anti-viral, neuropathic pain and some mental health disorders. PBG also has several product lines on the market, including the GenBioChem® line of natural health products, and various plant-based active pharmaceutical ingredients such as various cannabinoids and psilocybin for related industry application and clinical research.