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Our state-of-the-art manufacturing facilities have been designed and constructed to stringent current Good Manufacturing Practice (cGMP) standards.
The Zephex® facility in Cheshire, UK is the only one of its kind to have received an FDA audit, as well as inspections by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), ensuring we remain at the leading edge of industry cGMP compliance.
Zephex® 134a analytical techniques have been confirmed to be equivalent if not better than those described in the Norflurane European Pharmacopeia (EP) Monograph. Zephex® 134a meets the requirement of our more stringent Mexichem specification and the requirements of IPACT1.
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