FDA Drug Master File (DMF)

Click the button below to see the service steps in an easy-to-follow graphic format.

Load Infographic Close

What is a Drug Master File (DMF)?

A Drug Master File (DMF) is a confidential submission to the FDA that provides detailed information on the facilities, processes, and materials used in the manufacturing, processing, packaging, and storage of human drug products. A DMF must be submitted by:

Drug manufacturers of finished drug products.
Manufacturers of active pharmaceutical ingredients (APIs).
Producers of excipients, inactive ingredients, or packaging materials used in drug products.

A DMF typically includes details about the components or ingredients, the process technology, and the quality control measures for the drug substance, excipient, or packaging material. DMFs can also contain other types of information (e.g., toxicology information and shared system, Risk Evaluation and Mitigation Data REMS)

Does FDA Review & Approve the DMF?

The FDA neither approves nor disapproves DMFs. Instead, it reviews their technical contents in connection with applications that reference them (e.g., NDAs, ANDAs, INDs, and BLAs). The DMF is critical in supporting the review and approval of finished product drugs in NDAs, ANDAs, and INDs. Therefore, expert DMF preparation is essential for a successful submission.

Drug Master Files are especially prevalent for APIs and drug packaging materials. The applicant for the finished drug product cites the earlier submitted DMF in their submission, enabling the FDA to evaluate the information regarding the API or packaging material independently from the finished drug product.

What are the different types of Drug Master Files?

● TYPE II: Drug products, substances, intermediates, or materials used in drug preparation.
● TYPE III: Packaging material.
●TYPE IV: Excipient, colorant, flavor, essence, or material used in their preparation.
● TYPE V: FDA accepted reference information.

Role of FDA Agent in Preparation of DMF

● Identification of test requirements for type II and III DMFs.
● Expert review and organize DMF information.
● Finalize and submit DMF to the FDA.
● Fulfill DMF FDA Agent role.
● Communicating with the FDA on behalf of the client.
● Cost estimation and FDA fee payment assistance (if needed)
● Submitting DMF Annual Reports and Closure Request to the FDA.

What is the DMF Submission Fee?

For Fiscal Year 2025, the FDA has set the Drug Master File (DMF) submission fee at $95,084. This fee applies specifically to Type II DMFs associated with Active Pharmaceutical Ingredients (APIs) under the Generic Drug User Fee Amendments (GDUFA) program. Other DMF types—such as Type III (packaging materials), Type IV (excipients), and Type V (FDA-accepted reference information)—do not require a submission fee. The fee for FY 2026 is projected to increase to $102,584.

What are the Drug Master File Components ?

A DMF submission must include FDA Form 39381, a cover letter, and administrative and technical details. The FDA website offers several templates to help prepare the administrative information. The initial submission should provide comprehensive administrative and technical information, while follow-up submissions should only include details about changes and updates. The relevant electronic Common Technical Document eCTD modules for a DMF submission generally consist of the following:

-Cover letter: submission type and DMF holder’s statement of commitment

-Administrative information: DMF holder’s name and address, the agent and the manufacturer’s name, site address, and contact info.

-References: An Authorization Letter (LOA) to the DMF permits an applicant or sponsor to reference the DMF in an FDA application.

-REMS: The Risk Evaluation and Mitigation Strategy documents must be provided when applicable.

Depending on the DMF type, additional eCTD modules, such as application status, meeting requests, information amendments, and labeling documents, may be provided.

How can FDA Listing Inc Assist ?

Compliance with FDA DMF requirements can be complex and time-consuming, often requiring specialized expertise. FDA Listing Inc. streamlines DMF preparation and submission, helping your firm meet FDA requirements in the following ways:

Assistance with the preparation and organization of DMF technical and administrative information.
Submission of DMFs (Type II–V) to the FDA, including eCTD formatting.
Serving as your FDA Agent for communication with the FDA and handling DMF-related correspondence.
Support with annual reports, amendments, and closure requests.

Please email or call us if you need assistance with DMF preparation, FDA Agent services, or any DMF-related matter.

Service Details & Fees

2,450 USD

4-5 Days

_______ Related Services _______

Frequently Asked Questions (FAQ)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

U.S. FDA requires ﬁlling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After ﬁlling the Prior Notice, you will be assigned with a conﬁrmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be ﬁled by your own compnay or international transit ﬁrms as well as shipment companies (DHL, FedEx, TNT, etc).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

DMF preparation

2,450 USD

Time Required (Filing)

4-5 Days

U.S. Agent

DMF Review

30-Min Consultations

FDA Communications