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Invitrogen 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), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments to any of these. Invitrogen 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

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A typical DMF that Invitrogen 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

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As an Invitrogen customer using one of our products in a manufacturing process, you may request that we provide reference authorization to our Drug Master File(s) in support of a submission that you have made to the FDA. To initiate the reference authorization of our DMF, you must submit a Letter of Authorization request to Invitrogen 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 an Invitrogen Drug Master File is relevant to its review and that the agency has our approval to make that DMF part of your submission.

Confidentiality

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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.

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

  • Center for Drugs Evaluation and Research (CDER) - DMF # 17923
  • Center for Biologics Evaluation and Research (CBER) - CBER Requests can be referenced through CDER
  • Center for Devices and Radiological Health (CDRH) - DMF # MAF-1194

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

Products:

250X Cholesterol Lipid Concentrate - 12531 FGF-Basic Full Length CTS™
Recombinant Human - CTP0261
MesenPRO RS Kit -12746, 12747 & 12748
293 SFM II – 11686 FLT3 Ligand CTS™ Recombinant
Human - CTP9411
N-2 Supplement -17502
Adenovirus Expression Medium (AEM) – 12582 FLT3 Ligand CTS™ Recombinant
Human - CTP9413
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 GM-CSF CTS™ Recombinant Human - CTP2011 OptiMEM I - 31985
CD CHO 5 X Feed Kit 07-5004, 07-5005, 07-5006, 07-5007 GM-CSF CTS™ Recombinant Human - CTP2013 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 Stem Cell Factor CTS™ (SCF)
Recombinant Human - CTP2111
CD FortiCHO - A11483 Hybridoma SFM - 12045 Stem Cell Factor CTS™ (SCF)
Recombinant Human - CTP2113
CD Hybridoma Medium - 11279 Interleukin 2 CTS™ (IL-2)
Recombinant Human - CTP0021
StemPro MSC SFM XF - A10675, A10334 & A11577
CD Lipid Concentrate - 11905 Interleukin 2 CTS™ (IL-2)
Recombinant Human - CTP0023
StemPro MSC SFM CTS Kit - A10332, A10334 & A10333
CD OPTI CHO - 12681 Interleukin 4 CTS™ (IL-4)
Recombinant Human - CTP0041
Supplement S7 - US0175
CELLstart CTS A10142 Interleukin 4 CTS™ (IL-4)
Recombinant Human - CTP0043
Synth-a-Freeze CTS - A13713
CHO CD Efficient Feed Kit A-10241, A10234 & A10240 Interleukin 6 CTS™ Recombinant
Human - CTP0061
TGF-beta 1 CTS™ Recombinant
Human - CTP9211
CHO III PFM - 0960334 Interleukin 6 CTS™ Recombinant
Human - CTP0063
TGF-beta 1 CTS™ Recombinant
Human - CTP9213
CHO S SFM II – 12052 Interleukin 7 CTS™ (IL-7)
Recombinant Human - CTP0071
TNF-αlpha CTS™ Recombinant
Human - CTP3011
Defined Keratinocyte Combo - 10744, 10784 & 10785 Interleukin 7 CTS™ (IL-7)
Recombinant Human - CTP0073
TNF-αlpha CTS™ Recombinant
Human - CTP3013
DMEM – 11965 Keratinocyte SFM Combo - 17005, 10724, 37000, 13028 & 10450 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  
Express Five SFM - 10486 Knockout Serum Replacement (KSR) -10828  
FGF-Basic Full Length CTS™
Recombinant Human - CTP0261
Knockout SR XenoFree CTS - A10992