Drug Master Files 

A DMF is a reference source that provides drug evaluators 
confidential information not available to drug product 
manufacturers (sponsors) about the specific processes and 
components used in the manufacturing, processing and packaging of 
a drug. DMFs are divided into four types: 
- Type I: active pharmaceutical ingredients 
- Type II: packaging materials 
- Type III: colourants, flavours, and other additives 
- Type IV: drug products. 
A complete description of administrative procedures, data 
requirements and definitions related to DMFs is provided in the 
Drugs Directorate Guideline entitled Product Master Files 
(1994).