Thermo Fisher Scientific has submitted Drug Master Files to the US Food & Drug Administration for many of our products. Wherever you are in the world, contact our industry-leading regulatory experts to cross-reference a DMF or to provide information for your submissions to various government agencies.

DMF Overview

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 employed in the manufacturing, processing, packaging and storing of one or more drugs intended for use in humans or animals. Neither law nor FDA regulations require the submission of a DMF. The file is submitted solely at the discretion of the holder and is never approved or disapproved. The FDA will review information submitted only upon written request and reference given by the holder of the DMF. The DMF holder provides the written authorization to the FDA that allows the review of the Master File to support another regulatory application. The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), a Biologics License Application (BLA) , another DMF or amendments to any of these. Thermo Fisher Scientific submits DMFs on those products that have significant potential to be used in a manufacturing environment by our customers. There are several types of DMFs; we submit Type II files which are classified as either "Drug Substance," "Drug Substance Intermediate," or "Material" (used in the preparation of a drug product).

Typical Content of a DMF

 

A typical DMF that Thermo Fisher Scientific files for a cell culture product (such as nutrient media) may include the following:

  • A summary of all significant steps and controls in the manufacturing process
  • Product name and description
  • Formulation content, including raw materials used, specifications and other relevant information
  • Master production record
  • Product specifications
  • Packaging specifications

DMF Letter of Authorization

As a Thermo Fisher Scientific customer using one of our Gibco™ products in a manufacturing process, you may request that we provide reference authorization to our Drug Master File(s) in support of a submission or filing that you have made to the FDA. To initiate the reference authorization of our DMF, you must submit a Letter of Authorization request to Thermo Fisher Scientific requesting that we provide a DMF Letter of Authorization to the respective FDA Center. Once we have your request, we will advise the FDA that a Thermo Fisher Scientific Drug Master File is relevant to its review and that the agency has our approval to make that DMF part of your submission.

Confidentiality

All information contained in a Drug Master File is considered confidential to the holder. Neither the FDA nor other outside party may have access to or release the file without the holder's consent.

A consolidated Drug Master File (DMF) has been submitted to:

  • A consolidated Drug Master File (DMF) has been submitted to:Center for Drugs Evaluation and Research (CDER) - DMF # 17923 for Cell Culture Media
  • Center for Drugs Evaluation and Research (CDER) - DMF #25125 for Human Growth Factors
  • Center for Biologics Evaluation and Research (CBER) - CBER Requests can be referenced through CDER

A DMF can be referenced for catalog and customized versions of the following products:

DMF 17923 Products manufactured in Grand Island, New York, USA:

250X Cholesterol Lipid Concentrate - 12531
MesenPRO RS Kit -12746
293 SFM II – 11686   N-2 Supplement -17502
Adenovirus Expression Medium (AEM) – 12582   Neurobasal CTS - A13712
AIM V Medium CTS– 870112 Freestyle 293 Expression - 12338 Neurobasal A CTS - A13710
B-27 Supplement - 12587 GlutaMAX I CTS A12860 Opti-Pro SFM – 12309
CD 293 Medium – 11913   OptiMEM I - 31985
CD CHO 5 X Feed Kit 07-5004, 07-5005, 07-5006, 07-5007   OpTmizer CTS T-Cell Expansion SFM Kit - A10485, A10221 & A10484
CD CHO Media (25 X Concentrates) 0970194, 0970256, 0970360, 0970193, 0080044 Hanks Balanced Salt Solution (HBSS) - 14175 PFHM II – Liquid 12040
CD CHO Medium – 10743 Hibernate A CTS - A1370501 RPMI – 11875
CD DG44 Medium - 12610 Hibernate E CTS - A13706 SF 900 II SFM - 10902
CD EfficientFeed C AGT - A13275 Human Endothelia - 11111 SFM-19 Subcomponents 1 & 2
CD FortiCHO - A11483 Hybridoma SFM - 12045 HPFM-15 08-5033
CD Hybridoma Medium - 11279 CD Hybridoma AGT A27377
StemPro MSC SFM XF - A10675, A10334 & A11577
CD Lipid Concentrate - 11905 CTS Essential 8 Medium A26561
StemPro MSC SFM CTS Kit - A10332, A10334 & A10333
CD OPTI CHO - 12681   Supplement S7 - US0175
CELLstart CTS A10142   Synth-a-Freeze CTS - A13713
CHO CD Efficient Feed Kit A-10241, A10234 & A10240   HPFM-12 06-5056
CHO S SFM II – 12052   T Cell Serum Replacement Media Supplement A24344
Defined Keratinocyte Combo - 10744   B27 XenoFree CTS A1486701
DMEM – 11965 Keratinocyte SFM Combo - 17005
TrypLE ™ Select - 12563
DPM in-House Feed w/out Glucose - 0055044 Knockout DMEM CTS - A12861 VP SFM – 11681
EpiLife Basal Media - UMEPI500 Knockout DMEM/F12 CTS A13708 FunctiionMax Titer Enhancer A15010
Express Five SFM - 10486 Knockout Serum Replacement (KSR) -10828 DMEM/F12 11330
  Knockout SR XenoFree CTS - A10992 HEPES 15630

DMF 25125 Products manufactured in Frederick, Maryland, USA:

Recombinant Human Interleukin-2 (IL-2) CTS™  CTP0021 Recombinant Human Tumor Necrosis Factor-a (TNF-a) CTS™  CTP3011 Recombinant Human Transforming Growth Factor-β1 (TGF-  β1) CTS™  CTP9211
Recombinant Human Interleukin-2 (IL-2) CTS™  CTP0023 Recombinant Human Tumor Necrosis Factor-a (TNF-a) CTS™  CTP3013 Recombinant Human Transforming Growth Factor-β1 (TGF-  β1) CTS™  CTP9213
Recombinant Human Interleukin-4 (IL-4) CTS™  CTP0041 Recombinant Human Interleukin-6  (IL-6) CTS™  CTP0061 Recombinant Human Flt-3 Ligand CTS™  CTP9411
Recombinant Human Interleukin-4 (IL-4) CTS™  CTP0043 Recombinant Human Interleukin-6  (IL-6) CTS™  CTP0063 ecombinant Human Flt-3 Ligand CTS™  CTP9413
Recombinant Human Interleukin-7 (IL-7) CTS™  CTP0071 Recombinant Human Fibroblast Growth Factor-basic (FGF-basic) CTS™  CTP0261  
Recombinant Human Interleukin-7 (IL-7) CTS™  CTP0073 Recombinant Human Fibroblast Growth Factor-basic (FGF-basic) CTS™  CTP0263  
Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) CTS™ Recombinant Human Stem Cell Factor (SCF) CTS™  CTP2111  
Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) CTS™ CTP2011 Recombinant Human Stem Cell Factor (SCF) CTS™  CTP2113