Regulatory
DMF (Drug Master File)
Definition
A confidential file submitted to the US FDA with detailed information on how an API, excipient or packaging is made and controlled.
A Drug Master File lets a manufacturer give the FDA detailed and confidential information about its facilities, processes and controls without sharing it with its customers. A finished dose maker refers to the DMF in its own application through a letter of authorisation from the DMF holder.
Type II DMFs cover drug substances, intermediates and their materials, and are the most common in API trade. Type III covers packaging, Type IV excipients and Type V other reference information. In Europe, the equivalent route for APIs is the active substance master file (ASMF) or a CEP.
Related terms
- CEP (certificate of suitability)A certificate from the EDQM confirming that an API's quality is suitably controlled by the European Pharmacopoeia monograph.
- GMP (good manufacturing practice)Rules for making medicines, APIs, food and cosmetics so that every batch is consistently produced and controlled to its quality standard.
- USP grade (United States Pharmacopeia)Material that meets the USP or NF monograph, the drug and excipient standards recognised in US law.