Tetra Bio-Pharma Receives Second Compliant Rating on Inspection from Health Canada
Tetra Bio-Pharma has received a Notice of Compliance for its Drug Establishment License (DEL) from Health Canada, a key milestone for the commercialization of its Reduvo soft gel capsules. This follows a successful inspection confirming Tetra's compliance with pharmaceutical distribution regulations. The DEL is essential for the ongoing Drug Identification Number (DIN) review process. Tetra aims to bring Reduvo to market in 2021 as part of its wider strategy to provide cannabinoid-based treatments for various medical conditions.
- Received a Notice of Compliance for Drug Establishment License from Health Canada.
- Successful inspection confirms compliance for distributing pharmaceuticals.
- Progress in the Drug Identification Number review process for Reduvo.
- None.
- 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 / 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.
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.
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
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