Mexichem Fluor is the world leader in medical propellants and we have many years of experience operating to the highest current Good Manufacturing Practice (cGMP) standards. Our detailed understanding of the needs, standards and regulatory requirements of the pharmaceutical sector, coupled with our expertise in fluorine chemistry, makes us unique in our industry.
We are also developing new products, services and applications for the pharmaceutical industry.
Mexichem Fluor is the world’s largest supplier of hydrofluoroalkane (HFA) medical propellants, with over 75% of today’s HFA propelled metered dose inhalers (MDIs) filled with our medical propellants such as the world famous ZEPHEX®134a. We also offer the companion medical propellant ZEPHEX® 227ea.
All ZEPHEX® products are manufactured, tested and released fully in accordance with current Good Manufacturing Practice (cGMP), as expected by the world’s leading regulatory authorities, such as the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
Following inspections of the production facilities by the MHRA, Mexichem Fluor has received written confirmations that both ZEPHEX® 134a and ZEPHEX® 227ea are produced in accordance with the ICH guide to GMP for active pharmaceutical ingredients. ZEPHEX® HFAs are the only propellants to have received this level of approval from the MHRA.
Another testament to the high standards of Mexichem Fluor’s operations is the fact that some of the largest medical aerosol manufacturers have chosen to take all of their HFA propellants from us, indeed our customer list reads like a roll call of the MDI industry.
The propellant gas, in its security tagged stainless-steel container, is only one part of the ZEPHEX® offering available to pharmaceutical customers. As described on our website’s ‘Products and Services’ page, Mexichem Fluor offers ZEPHEX® customers a unique level of technical support. This includes the benefit of its collective knowledge and many years’ experience in areas as diverse as the transport and storage of liquefied gases, regulatory approvals and propellant analysis.
Recognising the need of its customers for specialised technical information, Mexichem Fluor has established the Customer Zone. This contains detailed information covering a wide range of topics and illustrates Mexichem Fluor’s commitment to provide its customers with technical know-how. In addition, to assist both existing and potential customers our website’s ‘Links and Introductions’ page contains a comprehensive set of links to other sites of interest.
Although Mexichem Fluor is the supplier of choice to some of the biggest MDI manufacturers, it takes an equally high standard of care with all its customers, generic or branded, large or small. Mexichem Fluor tries to meet each customer’s own individual needs and requirements.
Mexichem Fluor is active in assisting pharmaceutical companies around the world to make the transition from CFC propellants, traditionally used in metered dose inhalers (MDIs), to long-term products such as hydrofluoroalkanes (HFAs).
Our expertise enables us to help companies make the transition away from CFCs as quickly and as ‘seamlessly’ as possible, conscious that the needs of the patient are paramount.
While our business is the leading producer and supplier of HFA medical propellants and associated services – see the ZEPHEX® range – we recognise that there are still a small number of "essential use" applications where CFC propellants are still required to ensure ongoing patient care in the developing world.
Since 1 January 2010 any remaining CFCs that are required in the developing world, to provide ‘bridging’ to the new HFA propelled products, may have to come from a different source than used previously. Whilst we can no longer supply CFCs we are prepared to provide our expertise and advice in helping pharmaceutical companies ensure that any CFCs used by them are safe and fit for purpose.
To view our products please click www.zephex.com