NEWS ORLEANS, Ontario, Oct. 03, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), in partnership with Ford’s Family Pharmacy and Wellness Center, have developed and implemented a pharmaceutical quality system for Canada’s first botanical-based prescription drug PPP001. The Good Manufacturing Practices, Regulatory Operations and Regions Branch, Health Canada completed the inspection of Ford’s manufacturing facility. A Drug Establishment License (DEL) was granted after having inspected and assessed the facility as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulationsthereby allowing Ford’s to conduct the fabrication, packaging and labeling of PPP001.
Dr. Guy Chamberland, M.Sc., Ph.D., Interim CEO and CSO of Tetra Bio-Pharma stated, “This is a significant accomplishment for Tetra and Ford’s. The manufacturing of a botanical drug is a complex operation and we have demonstrated to Health Canada that we are able to manufacture PPP001 in compliance with the requirements for a prescription drug. The DEL was required not just to manufacture the commercial lots but simply to enable Tetra to apply for approval and obtain the Drug Identification Number (DIN). Tetra is now in an excellent position to focus its activities on scale-up to ensure that we can supply the market demand for a first cannabis botanical drug. The DEL, a recognition of the pharmaceutical GMP quality process by Health Canada, was a critical milestone for Tetra to achieve thereby allowing the corporation to accelerate its plans to register cannabis drugs around the world including Europe and the USA.”
Dr. Peter Ford, CEO of Ford’s Family Pharmacy and Wellness Centre stated, “This has been a true team effort between Tetra and Ford’s and will potentially represent the very first smokable dosage form in Canada and beyond. We are both very much committed to the DIN application.”
Ofer Yifrach-Stav, Tetra Bio-Pharma Vice President, Pharmaceutical Compliance and Quality, said, “Tetra is proud to present a significant milestone in the development of PPP001, a prescription drug that contains a botanical ingredient, manufactured under the stringent requirements and regulations of Health Canada. The GMP inspection addressed a wide range of production activities, and the results demonstrate our consistent adherence to establish procedures at every step of the production process, as well as our ability to provide a high-quality, clean, safe and reliable product. We are excited to take the next steps in the development of cannabis botanical drugs with the potential of making them widely available to the public.”