US Drug Master Files (US DMFs)
DMFs provide regulatory authorities with the relevant details of the manufacturing facilities, processes and quality of an API to support the drug product marketing authorization applications. DSM offers access to Type II DMFs (for Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product) for our vitamins and pharmaceutical omega-3 fatty acids, providing comprehensive product registration support in the US market.
Our global pharmaceutical portfolio is supported by documentation enabling registrations worldwide, including Japanese DMFs that allow the registration of products in Japan, Import Drug Licenses (IDLs) to support entry into the Chinese market, as well as other regional documentation to meet varying registration requirements globally.
Widely recognized across Europe, as well as countries such as Australia and Canada, CEPs are granted by the European Directorate for the Quality of Medicines (EDQM) and provide a streamlined approach during the assessments of product marketing authorization applications. Partnering with DSM for your API needs ensures your pharmaceutical developments are easy-to-manage, while saving you valuable time and resources.
Contact us to find out more about how our unique position and high standards can help bring your products to market more quickly.