Menu
Zephex® propellants are manufactured at industry leading facilities where all products are subject to a comprehensive quality control process involving eleven separate tests to confirm purity and quality.
Dedicated stainless steel containers are used for the supply of Zephex® at manufacturing scale, eliminating problems associated with conventional packaging common to the rest of the industry. A number of steps are taken to ensure the quality of each package we supply, including security tagging with a unique number recorded on the Certificate of Analysis. This certificate contains a hologram mark to assure customers they are receiving only pure Zephex® quality.
Koura’s detailed understanding of the needs, standards and regulatory requirements of our pharmaceutical customers combined with expertise in fluorine chemistry and chemical handling makes us unique in the manufacture of propellants for pharmaceutical uses.
Accreditations
Zephex® propellants are produced, tested and released from facilities dedicated to the production of pharmaceutical grades of HFA 134a and HFA 227ea. Zephex® products are made in accordance with current Good Manufacturing Practice (cGMP), as required by our customers, the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency.
FDA Audited
cGMP Compliant
MHRA Inspected