Drug Master Files

A Drug Master File (DMF) is a submission to the Food & Drug Administration [FDA] of information, usually concerning the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product, to permit the FDA to review this information in support of a third party's submission. Drug product information or other non-CMC information may be filed in a DMF. Currently, there are four Types of DMFs and they are:
  • II Drug substance, drug product, intermediates and material used in their manufacture
  • III Packaging
  • IV Excipients
  • V Other Sterile manufacturing plants, biotech contract facilities, clinical, tox
The Type II DMF contains the complete details of the manufacturing process for an active pharmaceutical ingredient [API] and is filed with the FDA.

DMF #

Status

Type

SUBMIT DATE

SUBJECT / API

11229

A

II

11/15/1994

ETOMIDATE MANUFACTURED IN ST. LOUIS, MISSOURI

12260

A

II

12/11/1996

PHENTOLAMINE MESYLATE, USP A BULK PHARMACEUTICAL, MANUFACTURED IN ST. LOUIS, MISSOURI

13006

A

II

5/28/1998

CLADRIBINE, MANUFACTURED IN ST. LOUIS, MISSOURI

15352

A

II

3/28/2001

FLOXURIDINE AS MFG IN ST. LOUIS, MO.

15900

A

II

3/15/2002

ADENOSINE AS MANUFACTURED IN ST.LOUIS, MO

16273

A

II

11/25/2002

HYALURONIDASE AS MANUFACTURED IN ST.LOUIS, MO.

17136

A

II

1/30/2004

FLUDARABINE PHOSPHATE AS MANUFACTURED IN ST. LOUIS, MO.

17248

A

II

3/22/2004

FENOLDOPAM MESYLATE, USP AS MANUFACTURED IN ST. LOUIS, MO.

19008

A

II

12/2/2005

PROTAMINE SULFATE USP AS MANUFACTURED IN ST. LOUIS, MO.

19038

A

II

12/15/2005

DALTEPARIN SODIUM AS MANUFACTURED IN ST. LOUIS, MO.

20226

A

II

1/31/2007

LYMPHOSEEK LIGAND AS MANUFACTURED IN ST LOUIS MO

21745

A

II

6/30/2008

CHLOROTHIAZIDE, USP AS MANUFACTURED IN ST.LOUIS, MO

22028

A

II

9/30/2008

COSYNTROPIN ACETATE AS MANUFACTURED IN ST. LOUIS, MO

23132

A

II

9/28/2009

DEXMEDETOMIDINE HCI AS MANUFACTURED IN ST LOUIS MO

RBC can provide a Letter of Authorization [LOA] to the client/sponsor who files a new drug application [NDA] or an abbreviated NDA [ANDA] referencing the DMF.  The FDA will review the DMF in conjunction with the NDA or ANDA.
test

Copyright © 2012 Reliable Biopharmaceutical Corporation NSPRD