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.
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(no longer applicable)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 |