Drug Master Files (DMFs)

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

 

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

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

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.

Invitrogen Cell Culture Products With DMFs

 

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:

Product Names

 

250X Cholesterol Lipid ConcentrateChemically Defined Lipid ConcentrateKnockout SR XenoFree
293 SFM IICELLstartMesenPRO RS Kit
Adenovirus Expression Medium (AEM)CHO III PFMOptiPRO™ SFM
AIM V® MediumCHO-S-SFM IIOpTmizer SFM Kit
CD 293 MediumDefined Keratinocyte-SFMPFHM II
CD CHO 5X Feed KitDMEMRPMI
CD CHO MediumExpress Five® SFMSf-900™ II SFM
CD DG44 MediumFreeStyle™ 293 Expression MediumStemPro MSC SFM
CD Hybridoma MediumHuman Endothelial-SFMTrypLE™ Select
CD CHO Efficient Feed KitHybridoma SFMVP-SFM
CD CHO Media (1 X Concentrate)Keratinocyte-SFM 
CD OptiCHO™ MediumKnockout Serum Replacement (KSR) 
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