A Drug Master File (DMF) is a submission to the USFDA or to the concerned regulatory authority, 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.

1. DRUG MASTER FILE
SUBMITTED BY
SUSANTA KUMAR ROUT
M.PHARM 2ND SEMESTER
DEPARTMENT OF PHARMACEUTICAL ENGINEERING &
TECHNOLOGY
IIT(BHU), VARANASI
SUBMITTED TO
DR. M.S. MUTHU
ASSOCIATE PROFESSOR
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2.  Introduction
 Types of DMF
 Submission of DMF
a) Transmittal letter
b) Administrative Information
c) Drug Specific Information
 Authorization to refer to a DMF
 Holder Obligation
 Closure of DMF
 Recent DMF filing & Top filers list(India& Global)
 Conclusion
DRUG MASTER FILE
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3. INTRODUCTION
• A Drug Master File (DMF) is a submission to the USFDA or to the concerned
regulatory authority, 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.
• Guidelines issued on September 1989 by USFDA.
• Provided in 21CFR 314.420.
• Not required by law of FDA regulation.
• Submitted solely at the discretion of the holder by API manufacturers.
• May used as support for various applications like IND, NDAANDA, or
Export Application but not as a substitute for these applications.
• Never approved or disapproved.
• DMF’s are only reviewed when an ANDA or NDA references them.
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4. WHO MUST FILE A DMF ?
• NOBODY!
• There is no regulatory requirements to file a DMF.
• It is a submission that indicates that the product of one’s company is a quality
product & meets the required standards
• DMF as a proof of reliability: API manufacturers with large number of DMF's
are often considered more reliable in terms of quality, regulatory standing, and
ability to meet cGMP requirements.
• DMF is considered as a degree of credibility(when any API manufacturers are
willing to sell there product in U.S or other regulated markets).
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5. TYPES OF DMF
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6. SUBMISSIONS TO DRUG MASTER FILES
• Submitted in CTD format, which has 2 parts one is Applicant’s/Open part &
another is Restricted/Closed part.
• Each DMF submission contains:
• A Transmittal letter
• An Adequate administrative information
• Drug specific information
• It must be written in English.
• Each page of DMF should be dated and consecutively numbered along with
updated table of content
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7. LETTER OF AUTHORIZATION(LOA)
• A written statement by the holder or designated agent of representative permitting
FDA to refer to information in the DMF in support of another person's submission.
• The letter of Authorization includes the following:
 The date.
 Name of DMF holder.
 DMF number.
 Name of person(s) authorized to incorporate information in the DMF by reference.
 Specific product(s) covered by the DMF.
 Submission date(s) of the above.
 Section numbers and/or page numbers to be referenced.
 Statement of commitment that the DMF is current and that the DMF holder will comply with
the statements made in it.
 Signature of authorizing official.
 Typed name and title of official authorizing reference to the DMF.
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9. HOLDER OBLIGATIONS
• Notice Required for Changes to a DMF
• Listing of Persons Authorized To Refer to a DMF
• Annual Update
• Appointment of an Agent
• Transfer of Ownership
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10. CLOSURE OF A DRUG MASTER FILE
• Should submit a request to the Drug Master File Staff stating
 The reason for the closure &
 A statement that the holder’s obligations have been fulfilled.
• The agency may close a DMF that does not contain an annual update of persons
authorized to incorporate information in the DMF (that of previous annual
reports).
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11. DMF FILING IN 2020
* Data obtained from USFDA website
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12. TOP 10 INDIAN DMF FILERS
TOP 10 DMF FILERS AT UDFDA
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13. RECENT DMF FILING BY MSN GROUP
• MSN Group is Hyderabad based pharmaceutical company founded in 2003.
• MSN currently has over 100 ANDAs & 710 DMFs(376 Active) and is world’s
no. 1 in Active US DMF Filings as per US FDA.
• Recently one DMF is filed by the MSN Life Sciences Pvt. Ltd. For the drug
Favipiravir on 26th December 2020.
HOLDER STATUS DMF NO. TYPE SUBMISSION DATE
MSN Life Sciences Pvt
Ltd
Active 35462 II 26.12.2020
FAVIPIRAVIR
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14. APPLICATIONS LIKE IND/NDA
 Comes under Regulatory Status.
 Each application & its supplement
are entered into a common database.
 Submitted to a particular review
division.
 Assignment to a reviewer & each
submission has a due date.
 Review procedure quite different
than DMF.
 If Annual update is missed, FDA
sends a reminder.
DMFs
 Not come under Regulatory status
as it’s not mandatory to file a DMF.
 DMFs are entered in to database as
per their types(separate database for
each type of DMF).
 Submitted to CDR.
 No assignment to reviewer, No due
date.
 DMFs are reviewed only when
referenced by application or another
DMF.
 If Annual update is missed, FDA will
not send a reminder.
DIFFERENCES BETWEEN IND/NDA/ANDA
APPLICATIONS & DMF APPLICATIONS
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15. CONCLUSION
• The DMF system presents challenges for both the industry and the FDA.
• Some of the changes have made the system smoother (hopefully for both industry and
FDA).
• Problems can be minimized:-
• With full understanding of their responsibilities and adherence to guidances on the part
of holders and applicants.
• With adherence to policies and procedures on the part of reviewers.
• 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.
• DMF may be used to support an IND, NDA, ANDA.
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16. REFERENCES
• https://www.fda.gov/
• https://www.researchgate.net/publication/327667709_DRUG_MASTER_FI
LE_GLOBAL_REGULATORY_ISSUES_AND_CHALLENGES
• https://www.fda.gov/drugs/drug-master-files-dmfs/guideline-drug-
master-files-dmf
• https://en.wikipedia.org/wiki/Drug_Master_File
• https://www.fda.gov/drugs/forms-submission-requirements/drug-
master-files-dmfs
• https://www.hilarispublisher.com/open-access/an-overview-of-drug-
master-files-2167-7689-1000198.pdf
• https://www.pharmaguideline.com/2017/09/drug-master-file-types-
dmf.html
• https://www.freyrsolutions.com/what-is-a-drug-master-file-dmf
• https://www.slideshare.net/ShrutiMotwani/drug-master-file-80622840
• https://www.slideshare.net/VrushaliSonar/drug-master-file-123491027
• https://www.slideshare.net/cyclonepharma/dmf-drug-master-file 16

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