Fermion has compiled Drug Master Files for innovative as well as generic drug substances.

Fermion's APIs have been registered worldwide; DMFs in CTD-format have been submitted to authorities in the United States, the European Union, Canada, Japan, Australia, New Zealand and other countries. 

In Europe, Certificates of Suitability have been received for a number of drug substances, and several applications are on-going. The Applicant's Part of a European DMF and Technical Packages referring to data contained in a US-DMF are available in electronic format (pdf). Fermion’s Regulatory Affairs department has many years’ experience in filing APIs in different regions and serves our customers in technical issues.