FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
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Drug Master File DMF
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A Drug Master File (DMF) is a secure submission to the FDA that contains confidential and detailed information about facilities, processes, or materials involved in manufacturing, processing, packaging, and storing human drug products. A drug manufacturer or manufacturers of active ingredients (API), inactive materials, or packaging materials will submit the DMF.
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)
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.
DMF Submission Fees
API manufacturers submitting a Type II DMF for generic drug applications must pay FDA fees. For the year 2024, the FDA DMF fee is USD 94,682. There are no fees for other types of DMF submissions.
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.
Service Details & Fees
DMF preparation
Time Required (Filing)
U.S. Agent
DMF Review
30-Min Consultations
FDA Communications
2,450 USD
4-5 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
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).
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).
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).
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).
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).
Frequently Asked Questions (FAQ)
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).
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).
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).
Service Details & Fees
DMF preparation
2,450 USD
Time Required (Filing)
4-5 Days
U.S. Agent
DMF Review
30-Min Consultations
FDA Communications
_______ Related Services _______