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Fresh news Tetra Bio-Pharma Granted

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Tetra Bio-Pharma Granted a Drug Establishment License to Distribute REDUVO Soft Gel Capsules in Canada 05/03/2021 The addressable market in Canada is estimated to be $80M CDN by 2022. 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. https://ir.tetrabiopharma.com/newsroom/press-releases/news-details/2021/Tetra-Bio-Pharma-Granted-a-Drug-Establishment-License-to-Distribute-REDUVO-Soft-Gel-Capsules-in-Canada/default.aspx