DuPont™ Dymel® 134a/P is a non-ozone-depleting alternative propellant for pharmaceutical applications. It is available for commercial use, is manufactured in full compliance with the U.S. Food and Drug Administration's (US FDA) "current Good Manufacturing Practices" (cGMP) and meets the requirements of health authorities worldwide. DuPont has a proven record of excellence as indicated by two deficiency-free inspections by the US FDA and by countless global customer audits. Our manufacturing site in Corpus Christi, Texas received very thorough and detailed inspections by the US FDA in 1995 and 1997. On both occasions, the plant was found to be in compliance and was not cited for any deficiencies. As a result, it has been designated by the US FDA as an approved site for the supply of pharmaceutical grade HFA-134a. No other HFA manufacturer in the world can claim this distinction.
DuPont owns and operates its own facilities and manages its own compliance. Dymel® 134a/P is manufactured in a separate facility that is cGMP compliant and dedicated solely to its production. This propellant and its blends are shipped throughout the world in dedicated containers ranging in size from 55 kg to 20 metric tons.
The chemical composition of Dymel® 134a/P is 1,1,1,2-tetrafluoroethane (HFA-134a) and the pharmaceutical grade has stringent purity and handling requirements.
DuPont supported the International Pharmaceutical Aerosol Consortium (IPACT-1) seeking alternative propellants for metered-dose inhalers. This included the supply of Dymel® 134a/P to IPACT-1 and individual pharmaceutical companies for toxicological and clinical evaluation. It also involved interaction with worldwide health authorities to ensure compliance with pharmaceutical requirements and governmental guidelines. Drug Master Files have been submitted worldwide. As a result, Dymel® 134a/P received affirmation from worldwide governmental bodies for use in metered-dose inhalers and other pharmaceutical applications.
Contact us to request an Access Letter to the DuPont™ Dymel® 134a Drug Master File in conjunction with your company's product approval.