Regulatory Compliance

CBE Pure Solutions state of the art facility is dedicated to clinical trial sterile filling, low bioburden manufacturing, and microbiological testing.

This facility offers world class and first in Australia qualified isolator technology for sterile fill and microbiological testing operations.

Our facility operates in adherence to high-quality GMP standards and are designed to deliver products to international compliance standards, ensuring patient safety.

CBE Pure Solutions, following comprehensive regulatory audits have been granted the following licences:

  • Code of Good Manufacturing Practice (cGMP) licensed by the Therapeutic Goods Administration (TGA) | Licence No. MI-2023-LI-08205-1

  • Code of Federal Regulations United States Food and Drug Administration (USFDA) | Facility Establishment Number FEI: 3032823828

  • Licence to Manufacture and Test Veterinary Chemical Products licensed by the Australian Pesticides and Veterinary Medicines Authority (APVMA) | Licence No. 1126

  • Licence to Manufacture and Sell or Supply by Schedule 8 or Schedule 9 Poisons (other than Heroin) Schedule 8 and limited Schedule 9. Licensed by the Victorian Department of Health and Human Services | Licence No. 21212984

  • Licence to Manufacture and Sell or Supply by Wholesale Poisons or Controlled Substances (other than Schedule 8 or Schedule 9 Poisons) Schedule 2, 3, 4 and limited Schedule 7. Licensed by the Victorian Department of Health and Human Services | Licence No. 23212860

  • Licenced to Manufacture and Test OGTR products with licenced PC2 Laboratory by Department of Health and Aged Care: Office of the Gene Technology Regulator | Certificate - 5081, 5082 and 5083

  • Licensed to handle Biosecurity Material Licenced by Department of Agriculture Fisheries and Forestry | Approved Arrangement V3597 and V3598