Tetra Bio-Pharma (OTC: TBPMF) Receives Second Compliant Rating on Inspection from Health Canada

April 1, 2021 admin Newsmakers Comments Off on Tetra Bio-Pharma (OTC: TBPMF) Receives Second Compliant Rating on Inspection from Health Canada
  • Tetra Bio-Pharma Inc. receives a Notice of Compliant rated inspection to distribute pharmaceuticals
  • Key milestone in the development path to commercialization of Reduvo

OTTAWA, ON/ April 1, 2021 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company”)(TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development announce they have received a notice of compliance for its Drug Establishment License (DEL) following an audit by the Drug GMP Inspection Program of Health Canada.

Guy Chamberland, CEO and CRO of Tetra Bio-Pharma stated, “This is a critical step in the regulatory process for drug approval. Tetra’s robust GMP quality management system is in place to ensure product quality and consumer safety. This Compliance rating signifies that we are one step closer to our goal of bringing Reduvo soft gel capsules to market in 2021.”

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Last month, Tetra announced it received a notice of compliance for its Quantum Pharma Inc. DEL to fabricate, package, and label pharmaceuticals. Today’s announcement is the issuing of a DEL to Tetra for the distribution of pharmaceuticals. Tetra’s DEL is required for continuing the DIN review process with Health Canada.

In December 2020, Tetra filled a New Drug Submission with Health Canada for Reduvo Soft Gel Capsules. If successful, it will provide Tetra with its first Drug Identification Number (DIN). In order to be authorized to distribute the drug to pharmacies across Canada, the Company is required to hold a DEL and is inspected by Health Canada to ensure compliance with Division 2 Part C of the Health Canada Food and Drug Regulations.

The inspection took place in March 2021 and during this period, the Company demonstrated to Health Canada that it can distribute prescription drugs in compliance with the requirements of the Food and Drug Regulations.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1) is a biopharmaceutical pioneer in immunomodulator drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. 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 biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.