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NEW Update *TBP* Second Compliant Rating from HC

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Tetra Bio-Pharma Receives Second Compliant Rating on Inspection from Health Canada

 

01 Apr 202102:00 ET

ACCESSWIRE

 

Tetra Bio-Pharma Inc. receives a Notice of Compliant rated inspection to distribute pharmaceuticalsKey milestone in the development path to commercialization of Reduvo

OTTAWA, ON / ACCESSWIRE / 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.

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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."

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.