FDA Drug Master Files Directory

$179 / year

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.

Complexity

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.

Date Created

2015-12-31

Last Modified

2020-07-10

Version

2020-07-10

Update Frequency

Quarterly

Temporal Coverage

1939-2020

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

DMF, Drug Evaluation and Research, New Drug Applications, Directory Submission, Submission List, Drug Master Files, Master Files, CDER

Other Titles

Drug Master Files, Drug Master Files List, DMF Submission List, DMF Directory, DMF Submissions

NameDescriptionTypeConstraints
DMF_IdDrug Master File ID numberintegerlevel : Nominal
Is_DMF_Status_ActiveIf 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_DMFType of DMF (Drug Master File).string-
Submission_DateDate of DMF submissiondate-
DMF_Holder_NamePerson/entity that owns the DMFstring-
DMF_SubjectThe Subject field specifies what the DMF covers e.g., “Sterile Processing Facility.string-
DMF IdIs DMF Status ActiveType of DMFSubmission DateDMF Holder NameDMF Subject
0FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1981-02-08HEXCEL CHEMICAL PRODUCTSCPC
1FalsePackaging Material1947-11-04ROHM AND HAAS COLETHANE 384 SPECIAL
2FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1943-05-08MONSANTO COSUCCINYL SULFATHIAZOLE
5FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1940-01-01NATIONAL RESEARCH COUNCILPENICILLIN
7FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1943-06-19WF STRAUB AND COHEXESTROL
8TrueExcipient, Colorant, FlaFDA-Accepted Reference Informationor, Essence, or Material Used in Their Preparation1950-01-01EASTMAN CHEMICAL COC-A-P(TM) CELLULOSE ESTER, NF (CELLACEFATE)
9FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1944-02-20NATIONAL RESEARCH COUNCILGELATIN & OTHER BLOOD SUBSTITUTES
11FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1944-03-12ROHM AND HAAS COHYAMINE X (QUATERNARY AMMONIUM CHLORIDE COMPOUND)
12FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1947-02-21NATIONAL RESEARCH COUNCILBAL IN OIL
13FalseDrug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product1945-01-01YEAST PRODS INCRIBOFLAVIN, ACETYLATED