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Tetra Bio-Pharma Moves PPP001 Closer to Commercial Manufacturing with the Issuance of a Drug Establishment License to Ford’s Pharmacy
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 Regulations thereby 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.”
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
About Ford's Family Pharmacy and Wellness Centre
Since 1997, Ford’s Family Pharmacy & Wellness Centre has helped clients improve and prolong their health, wellness and vitality by providing personalized compounding and wellness solutions. Our team, which currently consists of four pharmacists: Peter Ford, Bryan Sinclair, Candy Aguinaga, and Taylor White, 14 pharmacy technicians/assistants and two registered nurses, is attentive, compassionate, courteous and responsive. We pride ourselves on providing innovative solutions to complex medical problems, and work with Canadian healthcare providers (including physicians, veterinarians and dentists) to create well-rounded, comprehensive natural and compounding treatment plans. Our consultative approach, state-of-the-art technology and unique “Functional Medicine” position means we will work with you one-on-one to understand the root cause of your pain or other health issues and apply all our resources to developing the treatment that is right for you.
For more information visit: www.fordrx.com
Source: Tetra Bio-Pharma
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Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of PPP001, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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 legislation.
For further information, please contact Tetra Bio-Pharma Inc.
Executive Vice-President Corporate Development and Licensing
514-288-8500 ext. 226
416-425-9143 ext. 209