Glossary

Drug Master File (DMF)

What is Drug Master File (DMF)?

A Drug Master File (DMF) is a confidential document submitted to the Food and Drug Administration (FDA) that provides detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drug products.

What are the key points about DMFs?

DMFs are submitted at the discretion of the manufacturer, not required by law or regulation.
The information in a DMF is used to support regulatory submissions like INDs, NDAs, ANDAs, and export applications.
DMFs are not approved or disapproved by the FDA, but the technical contents are reviewed in connection with the review of applications that reference them.

What are the different types of DMFs?

There are five main types of Drug Master Files (DMFs) that cover different aspects of drug manufacturing:

Type I DMF

Manufacturing site, facilities, operating procedures, and personnel.
Typically used by foreign manufacturers to assist FDA in conducting on-site inspections.

Type II DMF

Drug substance, drug substance intermediate, and materials used in their preparation.
Drug product information.
Summarizes significant steps in manufacturing and controls for the drug substance or product.

Type III DMF

Packaging material information
Provides confidential detailed information about packaging components used for the drug product

Type IV DMF

Excipient, colorant, flavor, essence, or material used in their preparation
Identifies and characterizes each additive by its method of manufacture, release specifications, and testing methods

Type V DMF