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

Rhea-AI Summary

Tetra Bio-Pharma Inc. has announced that its contract facility, Quantum Pharma Inc., received a Drug Establishment License (DEL) compliance notice following a Health Canada audit. This achievement highlights the facility's ability to manufacture drugs such as QIXLEEF™ according to regulatory standards. The DEL was first obtained in 2018 and has since seen continuous quality improvements. CEO Guy Chamberland emphasized the significance of this compliant rating as a validation of Tetra's commitment to quality and adherence to pharmaceutical regulations.

Positive

• Quantum Pharma received notice of compliance for its Drug Establishment License from Health Canada.
• Demonstrated ability to manufacture drugs like QIXLEEF™ in compliance with regulations.
• Continuous improvement of quality management since obtaining the DEL in 2018.

Negative

• None.

• Quantum Pharma Inc. is a contract facility operated by Tetra Bio-Pharma Inc
• Quantum Pharma Inc. receives a Notice of Compliant rated inspection

OTTAWA, ON / ACCESSWIRE / March 18, 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 that its contract manufacturing facility, Quantum Pharma Inc., 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 major step forward for Tetra. The manufacturing of any prescription drug is a complex operation that takes expertise and dedication to achieve high quality standards."

The facility first obtained the DEL in 2018. Since then, Tetra has continuously improved its quality management system to ensure compliance with Health Canada's GMP requirements. The inspection took place in February 2021 and during this period, Tetra demonstrated to Health Canada that it can manufacture drugs, such as QIXLEEF™, in compliance with the requirements for a prescription drug.

Guy Chamberland, added, "Maintaining a Compliant Rating (C) for a DEL is not an easy task as it is the recognition of the pharmaceutical GMP quality process by Health Canada. We are very proud of the team at Tetra. This is another sign to shareholders that we are committed to working and operating by the rules set by drug regulators like Health Canada and the U.S. Food and Drug Administration and delivering high quality pharmaceutical medications to patients."

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.

Forward-looking statements

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 this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, 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. 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.:

Tetra Bio-Pharma Inc.
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
Email: Investors@tetrabiopharma.com
Media@tetrabiopharma.com

SOURCE: Tetra Bio-Pharma

View source version on accesswire.com:
https://www.accesswire.com/636150/Tetra-Bio-Pharma-Receives-Compliant-Rating-on-Inspection-from-Health-Canada

FAQ

What recent compliance achievement did Tetra Bio-Pharma Inc. announce in March 2021?

Tetra Bio-Pharma Inc. announced that its contract facility, Quantum Pharma Inc., received a notice of compliance for its Drug Establishment License from Health Canada.

How does the Drug Establishment License compliance impact Tetra Bio-Pharma's operations?

The compliance indicates Tetra's capability to manufacture prescription drugs under Health Canada's quality standards, which is crucial for its pharmaceutical operations.

What products can Quantum Pharma manufacture under the compliance received by Tetra Bio-Pharma?

Quantum Pharma can manufacture prescription drugs, including QIXLEEF™, under the compliance received.

When did Tetra Bio-Pharma first obtain its Drug Establishment License?

Tetra Bio-Pharma first obtained its Drug Establishment License in 2018.

What did CEO Guy Chamberland say about the compliance rating received by Tetra Bio-Pharma?

CEO Guy Chamberland stated that maintaining a compliant rating is a significant achievement and reflects the company’s dedication to high-quality standards in pharmaceuticals.