What is contained in a Drug Master File (DMF)?

A Drug Master File (DMF) primarily contains confidential information related to the manufacturing processes, quality control measures, and specific components used in the production of a drug. This file serves to provide extensive details that can support the regulatory review process for drug applications without disclosing proprietary information to the public or competitors.

The primary purpose of a DMF is to facilitate submissions to the FDA by allowing a manufacturer to provide relevant information that supports the safety and efficacy of their drug products while keeping sensitive operational data private. This can include details about the facilities where the drug is manufactured, the specific methods used in production, and the raw materials employed.

In contrast, other options such as a summary of drug indications and usage, publicly available safety data, and marketing strategies do not fit the specific purpose of a DMF. Indications and usage information is typically included in the drug's label or prescription information, safety data is made public through clinical trial results or FDA communications, and marketing strategies are handled separately from the technical data provided in a DMF.