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
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.