Drug Master Files
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.
Nov 16th 2011