Ms. Natalie Leroux reports
TETRA BIO-PHARMA GRANTED A DRUG ESTABLISHMENT LICENSE TO DISTRIBUTE REDUVO SOFT GEL CAPSULES IN CANADA
Tetra Bio-Pharma Inc. has been granted a Health Canada drug establishment licence (DEL) to distribute Reduvo soft gel capsules in Canada. Reduvo is a synthetic tetrahydrocannabinol-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 1, 2021, the company announced it had received a compliant rated good manufacturing practices inspection by Health Canada. Subsequently, Health Canada finalized its 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 licence (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 chief executive officer, Dr. Guy Chamberland.
About Tetra Bio-Pharma Inc.
Tetra 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 health care providers. Its evidence-based scientific approach has enabled the company 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 the company does, 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.
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