FDA Drug Master Files (DMF)

A Drug Master File (DMF) is a confidential submission to FDA containing detailed information about a facility, process, or article used in manufacturing, processing, packaging, or storing drugs. LMG assists with DMF preparation and submission.

21 CFR 314.420API & ExcipientseCTD FormatConfidential Submission

Drug Master File Services

A Drug Master File (DMF) is a submission to the U.S. Food and Drug Administration (US FDA) that may provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not an FDA requirement by law or US FDA regulation. A DMF Submission is solely at the discretion of the DMF holder. The information contained in the 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 amendments and supplements to any of this submission.

A DMF is not a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved; technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application. US FDA will issue a DMF number to each submission. DMF number does not denote registration of the facility or product. The US FDA is not issuing a certificate of FDA registration, nor does the US FDA recognize a registration certificate issued by a third party. FDA encourages foreign DMF holders to appoint a U.S. FDA Agent.

A Drug Master File (DMF) becomes necessary when confidential information that a manufacturer does not wish to share with the applicant. The FDA requirements for each type of DMF are different; Liberty Management Group’s experienced consultants can help you identify the FDA DMF requirements for your product. Our consultant can help you in the preparation and submission of DMF. LMG also provides US FDA Agent service for foreign manufacturers.

DMF Preparation & Submission

Complete preparation, eCTD conversion and submission of your Drug Master File — Type I, Type II , Type III, Type IV, or Type V — to the FDA.

U.S. Agent for DMF

Foreign DMF holders must designate a U.S. Agent. LMG serves as your official FDA Agent — receiving all FDA communications related to your DMF.

Annual DMF Update

DMF holders must submit an annual update confirming the DMF is current. LMG prepares and submits your annual DMF update letter to FDA.

Authorization Letter

When an NDA/ANDA applicant references your DMF, they need a Letter of Authorization. LMG prepares these authorization letters for DMF holders.

How It Works

We manage the entire process from start to finish — so you can focus on your business.

DMF Type Assessment

We determine the correct DMF type for your facility and product, API, packaging material, or excipient.

eCTD Conversion

We convert your complete DMF in to an FDA required format — Electronic Common Technical Document.

FDA Submission

We submit your DMF electronically to FDA through the Electronic Submissions Gateway and provide the DMF number.

Annual Maintenance

We manage annual DMF updates and authorization letters to keep your DMF in active status.

Frequently Asked Questions

Common questions about this FDA regulatory service.

What is a Drug Master File (DMF)?

A DMF is a voluntary confidential submission to FDA that contains detailed information about a facility, process, or article used in drug manufacturing. It allows drug manufacturers to reference the DMF in their NDA or ANDA without disclosing confidential information.

What types of DMFs does FDA accept?

FDA accepts Type II (API/drug substance), Type III (packaging material), Type IV (excipient), and Type V (FDA-accepted reference information). Type I (manufacturing site) is no longer accepted for new submissions.

Do foreign API manufacturers need a U.S. Agent for a DMF?

Yes. Foreign DMF holders must designate a U.S. Agent who is physically located in the United States and can receive FDA communications on their behalf.

Is a DMF required or voluntary?

Filing a DMF is voluntary — but it may be required by drug product manufacturers who reference your API, excipient, or packaging material in their NDA or ANDA applications.