Drug Master Files (DMF)
A Drug Master File (DMF) is a submission to the U.S. Food and Drug Administration (US FDA) that may be used to 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 by 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. US FDA is not issuing a certificate of FDA registration nor does US FDA recognize a registration certificate issued by third party. FDA encourages foreign DMF holders to appoint a U.S. FDA Agent.
A Drug Master File (DMF) becomes necessary when there is confidential information that a manufacturer does not wish to share with the applicant. The FDA requirements for each type of DMF's are different; Liberty Management Group's experienced consultants can help you to 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.
TYPES OF DRUG MASTER FILES (DMF)
There are five types of DMF:
Type I DMF Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).
Type II DMF Drug Substance, Drug Substance Intermediate, and Material Used in their Preparation, or Drug Product.
Type III DMF Packaging Material.
Type IV DMF Excipient, Colorant, Flavor, Essence, or Material Used in their Preparation.
Type V DMF FDA Accepted Reference Information./
DMF Submission Fees
Type II DMF Submission from an API Manufacturer for a generic drug application need to pay FDA fees. The FDA DMF Fees for the year 2020 is USD 57,795. There are no FDA fees for other types of DMF submissions.
Our consultants can assist you to fulfill the US FDA DMF requirements, Our DMF Submission services includes.
- Identification of test requirements (for type II DMF and III DMF).
- Identification of testing lab (for type II DMF and III DMF).
- Edit and organize DMF information.
- Submitting DMF to FDA.
- US FDA DMF Agent service.
- Communicating with FDA on behalf of our client.
- Assisting clients to issue LOA (letter of authorization) to FDA.
- Assistance with DMF Annual report submission to FDA.
- Assistance in DMF Closure request submission to FDA.
- Assistance in DMF Reactivation request submission to FDA. (for closed DMF)