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| MEDICAL PRODUCTS |
 With an innovative team of people, many years of experience in fluorine technology and dedicated production facilities, Mexichem Fluor has always been at the leading edge of defining the standards of current Good Manufacturing Practice (cGMP) for propellant manufacture. ZEPHEX®134a and ZEPHEX®227ea are produced, analysed and distributed in full accordance with the requirements of cGMP. Regularly inspected by the UK MHRA, Mexichem Fluor´s approval letters for both production facilities for ZEPHEX® are available. MHRA Certificate 2009 (Registered Only!) Mexichem Fluor provides a comprehensive regulatory support package for all countries. Having been involved with the regulatory approval processes for HFA propellants from the time they were first identified as replacements for the cholorofluorocarbons (CFCs), Mexichem Fluor has the background knowledge and experience to facilitate customer product approvals, and to respond to regulatory requirements for HFA propellants. Drug Master Files for ZEPHEX®134a have been filed with and reviewed by the US FDA and the Canadian TPD. A Drug Master file for ZEPHEX®227ea has been filed with the US FDA. For other markets and regions Mexichem Fluor can provide, under obligation of confidentiality, the information concerning ZEPHEX® propellants, which is required to support regulatory approvals. Aligned with the requirements of the ICH Common Technical Document, Mexichem Fluor´s regulatory documentation package is suitable for inclusion in Section 3.2.P.4 of the European Union´s CTD for the authorisation of medicinal products. This package also supports ZEPHEX® propellants in all other markets and regions. If necessary, this package can be tailored to meet the particular requirements of either a customer or a regulatory agency. |
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