Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) announced Thursday that the company received a notice of compliance for its Drug Establishment License (DEL) following an audit by the Drug GMP (good manufacturing practice) Inspection Program of Health Canada related to its Reduvo cannabinoid soft gel capsules.
“This is a critical step in the regulatory process for drug approval,” CEO Guy Chamberland said in a statement. “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.”
The notice was the company’s second received in as many months. In March, the biopharmaceutical company said its contract manufacturing facility, Quantum Pharma Inc, received a DEL to fabricate, package, and label pharmaceuticals.
READ: Tetra Bio-Pharma gets Health Canada approval to file clinical trial application for ARDS-003 study on coronavirus patients
An inspection also took place that month, during which the company demonstrated to Health Canada that it can distribute prescription drugs in compliance with the requirements of the food and drug regulations.
Accordingly, the new DEL applies to the distribution of pharmaceuticals, the company said. Such a DEL is required for continuing the Drug Identification Number (DIN) review process with Health Canada.
In December, Tetra filled a New Drug Submission with Health Canada for its Reduvo soft gel capsules. If the process is successful, Health Canada will provide Tetra with its first DIN.
Contact Andrew Kessel at [email protected]
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