Pharma Solutions

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.  

Worldwide DMFs 

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.   

CEPs 

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.

November 14, 2017
Events
DSM speaks at Nicholas Hall OTC Conference READ MORE
October 25, 2017
Science
The Roles of Lipids in the Most Recent History of Cancer Prevention READ MORE
October 24, 2017
Science
The Effect of Vitamin E on Cardiovascular Risk Reduction READ MORE
September 18, 2017
Events
DSM Brings New Innovative Therapeutic Concepts to CPHI 2017 READ MORE
September 7, 2017
Events
Webinar: Emerging roles of lipids in the modulation of cancer risk and therapy READ MORE
August 23, 2017
Science
Boosting public health with vitamins for pharmaceutical applications READ MORE