Drug Master File

A Drug Master File [DMF] is a submission to the Food and Drug Administration (FDA) that provides the regulatory authority with confidential, detailed information about facilities, processes or articles used in the manufacturing, packaging, processing, and storing of one or more human drugs.

A DMF is neither approved nor rejected; it is reviewed by the FDA when referenced by an applicant in a regulatory submission. It contains the chemistry, manufacturing, and controls of a drug component.

The information involved in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or related documents.

There Are Five Types Of DMFs:

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer relevant)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product
  • Type III Packaging materials, from bottles and caps to PVC resin used in their manufacture must be covered in a DMF or another FDA document such as an NDA.
  • (Note: There appears to be some confusion regarding when a Type III Drug Master File (packaging material) should be submitted. It is not required that packaging information is submitted to the FDA in a Drug Master File. This information may be provided to the applicant by the manufacturer of a packaging component or material of construction and may be included directly in the application.

    Any information that a manufacturer does not wish to share with the applicant or sponsor may be placed in a Type III Drug Master File and incorporated into the application by a letter from the manufacturer to the applicant which authorizes reference to the Drug Master File.)

  • Type IV Excipient, Colorant, Flavors, Essence, or Materials Used in their Preparation.
  • Type V FDA Accepted Reference Information not included in the other types.

The FDA makes sure that the DMFs are up to date. If a company has not submitted an annual report in for three years, the agency sends an “Overdue Notification Letters” to DMF owners. The owner has 90 days in which to respond and submit its annual report. If they fail to respond, their DMF may be closed.

MedDeviceCorp DMF Consultants will guide you with the entire process, prepare, edit and submit through our US Agent.

  • Arrange and guide in supporting documentation.
  • Guidance on Chemistry, Manufacturing, and Controls.
  • Identification of test requirement.
  • Edit and organize information.
  • Appointing the US Agent.
  • Submit to the FDA.
  • Inform changes to the FDA.
  • Annual report submission.
  • Communicating with the FDA on behalf of our client.
  • Assisting clients to issue LOA (letter of authorization).
  • Current Good Manufacturing assessment (GMP GAP Analysis).
  • Environmental assessment as per 21 CFR part 25.

DMF (Drug Master Files)

US Drug Master Files (DMFs) is a submission to the US FDA the confidential information about facilities, processes or components used in the manufacturing, processing, packaging and storing of one or more human drugs.

Our experts will guide you the entire process, prepare, edit and submit through our US Agent.

    • Arrange and guide in supporting Documentation.
    • Guidance on Chemistry, Manufacturing, and Controls.
    • Identification of test requirement.
    • Edit and organize information.
    • Appointing the US Agent.
    • Submit to FDA.
    • Inform changes to FDA.
    • Annual report submission.
    • Communicating with FDA on behalf of our client.
    • Assisting clients to issue LOA (letter of authorization).
    • Current Good Manufacturing assessment (GMP GAP Analysis).
    • Environmental assessment as per 21 CFR part 25.

Contact us for more information enquiry@meddevicecorp.com