- Drug Master Files
- Drug Master Files List
- DMF Submission List
- DMF Directory
- DMF Submissions
- Drug Evaluation and Research
- New Drug Applications
- Directory Submission
- Submission List
- Drug Master Files
- Master Files
FDA Drug Master Files Directory
This dataset contains a list of the Drug Master Files (DMF) submitted to the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) since 1900 to the current date. Drug Master Files are submitted by pharmaceuticals (holders) to the CDER providing confidential information on facilities, processes and articles implemented in the production of human drugs.
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A Drug Master File (DMF) is a submission to the Food and Drug Administration (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 required by law or FDA regulation. A DMF is submitted solely at the discretion of the 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 these.
A DMF is NOT a substitute for an IND (Investigational New Drug), NDA (New Drug Application), ANDA (Abbreviated New Drug Application) 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.
This guideline does not impose mandatory requirements (21 CFR 10.90(b)). It does, however, offer guidance on acceptable approaches to meeting regulatory requirements. Different approaches may be followed, but the applicant is encouraged to discuss significant variations in advance with FDA reviewers to preclude spending time and effort in preparing a submission that FDA may later determine to be unacceptable.
Drug Master Files are provided for in 21 CFR 314.420. This guideline is intended to provide DMF holders with procedures acceptable to the agency for preparing and submitting a DMF. The guideline discusses types of DMF’s, the information needed in each type, the format of submissions to a DMF, the administrative procedures governing review of DMF’s, and the obligations of the DMF holder.
DMF’s are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DMF.
DMF’s are submitted in an optional manner and the information can be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF or an Export Application. There are five types of DMF according to the information contained, and each DMF should contain only one type of information.
About this Dataset
John Snow Labs; U.S. Food and Drug Administration (FDA);
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DMF, Drug Evaluation and Research, New Drug Applications, Directory Submission, Submission List, Drug Master Files, Master Files, CDER
Drug Master Files, Drug Master Files List, DMF Submission List, DMF Directory, DMF Submissions
|DMF_Id||Drug Master File ID number||integer||level : Nominal|
|Is_DMF_Status_Active||If the value is "true" this means that the DMF was found acceptable for filing, administratively, and has not been closed. “false” this means a DMF that has been closed, either by the holder or by the FDA. Numbers for DMFs that are Cancelled, Preassigned and Pending or have been transferred to another center in the FDA are not included in the list. The status conveys no information about whether a DMF has been reviewed for technical content or whether it has undergone a Completeness Assessment.||boolean||-|
|Type_of_DMF||Type of DMF (Drug Master File).||string||-|
|Submission_Date||Date of DMF submission||date||-|
|DMF_Holder_Name||Person/entity that owns the DMF||string||-|
|DMF_Subject||The Subject field specifies what the DMF covers e.g., “Sterile Processing Facility.||string||-|
|DMF Id||Is DMF Status Active||Type of DMF||Submission Date||DMF Holder Name||DMF Subject|
|0||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1981-02-08||HEXCEL CHEMICAL PRODUCTS||CPC|
|1||False||Packaging Material||1947-11-04||ROHM AND HAAS CO||LETHANE 384 SPECIAL|
|2||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1943-05-08||MONSANTO CO||SUCCINYL SULFATHIAZOLE|
|5||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1940-01-01||NATIONAL RESEARCH COUNCIL||PENICILLIN|
|7||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1943-06-19||WF STRAUB AND CO||HEXESTROL|
|8||True||Excipient, Colorant, FlaFDA-Accepted Reference Informationor, Essence, or Material Used in Their Preparation||1950-01-01||EASTMAN CHEMICAL CO||C-A-P(TM) CELLULOSE ESTER, NF (CELLACEFATE)|
|9||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1944-02-20||NATIONAL RESEARCH COUNCIL||GELATIN & OTHER BLOOD SUBSTITUTES|
|11||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1944-03-12||ROHM AND HAAS CO||HYAMINE X (QUATERNARY AMMONIUM CHLORIDE COMPOUND)|
|12||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1947-02-21||NATIONAL RESEARCH COUNCIL||BAL IN OIL|
|13||False||Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product||1945-01-01||YEAST PRODS INC||RIBOFLAVIN, ACETYLATED|