Tetra Bio-Pharma Granted a Drug Establishment License to Distribute REDUVO Soft Gel Capsules in Canada
Tetra Bio-Pharma has received a Drug Establishment License from Health Canada to distribute REDUVO soft gel capsules, a synthetic THC product aimed at treating severe nausea from chemotherapy. As part of the regulatory process, Tetra is also applying for a Cannabis Drug License. This development positions Tetra favorably in the estimated $80M CDN Canadian market. The company confirmed plans to launch REDUVO in late 2021 and completed a compliant GMP inspection.
- Tetra Bio-Pharma received Health Canada's Drug Establishment License to distribute REDUVO soft gel capsules.
- The Canadian addressable market for cannabis drugs is estimated at $80M CDN by 2022.
- Successful completion of a compliant GMP inspection by Health Canada.
- None.
The addressable market in Canada is estimated to be
Tetra also applies for a Health Canada Cannabis Drug License
OTTAWA, ON / ACCESSWIRE / May 3, 2021 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a leader in cannabinoid-derived drug discovery and development today announced that the Company has been granted a Health Canada Drug Establishment License (DEL) to distribute REDUVO soft gel capsules in Canada. REDUVO is a synthetic THC-based soft gel capsule indicated in severe nausea and vomiting associated with cancer chemotherapy and is currently being assessed by Health Canada for the issuance of a Drug Identification Number (DIN). REDUVO, known as Marinol in the United States, has been approved as a regulated pharmaceutical drug by the U.S. Food and Drug Administration since 1985.
On April 01, 2021, the Company announced it had received a compliant rated GMP inspection by Health Canada. Subsequently, Health Canada finalized their regulatory assessment and determined that Tetra met all the requirements for the issuance of a DEL. In Canada, any company that intends to distribute pharmaceutical drugs must obtain a DEL as per Health Canada regulatory requirements. It is a comprehensive and stringent process to obtain a DEL approval as a company must demonstrate it meets strict quality control standards and procedures. Further, any company that intends to distribute pharmaceutical drugs that contain cannabis must also obtain a Health Canada Cannabis Drug License (CDL). Only companies, such as Tetra Bio-Pharma, with a Health Canada issued DEL are eligible to apply for a CDL. Tetra confirms that is has submitted the CDL application to Health Canada and the application is in queue for review.
"We look forward to working closely with our Contract Manufacturing Organization for the importation, warehousing, and dissemination of the THC pharmaceutical drug to pharmacies across Canada. We stand by our commitment to launch our THC-based prescription drug to the Canadian market in late 2021," commented Tetra's CEO, Dr. Guy Chamberland.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1) is a leader in cannabinoid-derived 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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FAQ
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