Tetra Bio-Pharma Inc. (TSX:TBP) (OTCQB:TBPMF) (FRA:JAM1) has announced that its contract manufacturing facility, Quantum Pharma Inc., has received a notice of compliance for its Drug Establishment License (DEL) following an audit by the Drug GMP Inspection Program of Health Canada.
The facility first obtained the DEL in 2018. Since then, Tetra said it 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.
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In a statement, Guy Chamberland, CEO and CRO of Tetra Bio-Pharma commented: "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."
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 US Food and Drug Administration (FDA) and delivering high-quality pharmaceutical medications to patients."
Tetra Bio-Pharma is a pioneer in immunomodulator drug discovery and development with a US FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
Its 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 it does, the company is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
Contact the author at jon.hopkins@proactiveinvestors.com