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Drug Master Files

Important Guidance Information  See below

IMPORTANT ADDRESS INFORMATION

Please note that the current address for the Central Document Room for filing original DMFs and subsequent DMF documents is now:

Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Beltsville MD 20705-1266

Submissions mailed to the old address will also be forwarded to the new address for a period of time.  If you have previously submitted an original DMF or subsequent DMF document to the old address please DO NOT resubmit it to the new address

This site contains lists of Drug Master Files (DMFs) as well as information concerning submission of DMFs. See below for information regarding the current DMF Guideline.

The list of DMFs is current as of September 30, 2004, through DMF 17678. Changes to the DMF activity status, DMF type, holder name, and subjects made since the last update of June 30, 2004 are included. The lists are updated quarterly.

For people who downloaded the previous list (through DMF 17480 June 30, 2004) and do not wish to download the entire updated lists the following lists are available:
 

1. New DMFs since the last list.

2. A list of changes in DMF activity status, DMF type, holder name, and subject.

The lists are available in Microsoft Excel and in ASCII (Tab-delimited).  Please note that only ACTIVE DMFs have been sorted into different types.

  • All DMFs

  • Active DMFs

  • Active Type II DMFs

  • Active Type III DMFs

  • Active Type IV DMFs

  • Active Type V DMFs

  • New DMFs since the last list

  • Changes

The types of DMFs are:

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)

  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

  • Type III Packaging Material

  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

  • Type V FDA Accepted Reference Information

 

All files zipped (2.7 MB)

“A” = Active

“I” = Inactive

“N” = Not an assigned number

“P” = DMF Pending Filing Review

The criteria for judging a DMF to be inactive include:

1. The holder requested that the DMF be retired or inactivated.

2. DMFs filed before September 30, 2001 which have had no activity since they were filed or have had no activity since September 30, 2001.

 Note that a Letter of Authorization is not considered to qualify as an amendment or update.

As discussed in the "Guideline for Drug Master Files" (September 1989), DMF holders should update their DMFs annually. 

Some DMFs may be listed as inactive which are, in fact, still active.  Every effort will be made to correct any errors.

Please address ALL comments or questions regarding DMFs to dmfquestion@cder.fda.gov.  All inquiries MUST have an entry in the "Subject" field of the e-mail.  Due to concerns about viruses and the amount of "spam" received by this account, e-mails with subject fields containing meaningless text strings, only questions marks, or left blank will not be opened.

 Other inquiries unrelated to DMFs should go to druginfo@cder.fda.gov.

GUIDANCES

DMF Guideline  The version posted on the web is the current version.  No revision is planned for the immediate future. Please address question regarding the DMF Guideline to dmfquestion@cder.fda.gov

Type I DMFs

Type I DMFs are no longer accepted per a Final Rule published January 12, 2000 (65 FR 1776.)  See Type V DMFs below.

Type II DMFs

Type II DMFs may be submitted in the format for "Drug substance" in the "Guidance for Industry  M4Q: The CTD - Quality".  Note that this is not required. 

Drug Substance:

The current Guideline for Drug Substances cited in the DMF Guideline is in the process of being revised.  Draft Guidance for Industry:  Drug Substance:  Chemistry, Manufacturing, and Controls Information was posted on January 6, 2004

Drug Product:

There is a draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information.

Type III DMFs

The applicable Guidance for Type III DMFs is the “Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics:  CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION”  and Questions and Answers.

Type V DMFs

DMFs to describe Manufacturing Site, Facilities, Operating Procedures, and Personnel for sterile manufacturing plants may be filed as Type V DMFs.  It is not necessary to request prior clearance from FDA before filing such DMFs.  See Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products.

Similarly DMFs to describe contract facilities for the manufacture of biotech products may be filed as Type V Master Files without prior clearance from FDA.  See Draft Guidance for Industry:  Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research

ELECTRONIC DMFS

See Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions. To make sure you have the most recent versions of the specifications referenced in this guidance please check Electronic Common Technical Document (eCTD).

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Date created: April 17, 2001; updated October 25, 2004

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