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.
Typical Content of a DMF
A typical DMF that Invitrogen files for a cell culture product (such as nutrient media) may include the following:
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.
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 DMF can be referenced for catalog and customized versions of the following products:
|250X Cholesterol Lipid Concentrate||Chemically Defined Lipid Concentrate||Knockout SR XenoFree|
|293 SFM II||CELLstart||MesenPRO RS Kit|
|Adenovirus Expression Medium (AEM)||CHO III PFM||OptiPRO™ SFM|
|AIM V® Medium||CHO-S-SFM II||OpTmizer SFM Kit|
|CD 293 Medium||Defined Keratinocyte-SFM||PFHM II|
|CD CHO 5X Feed Kit||DMEM||RPMI|
|CD CHO Medium||Express Five® SFM||Sf-900™ II SFM|
|CD DG44 Medium||FreeStyle™ 293 Expression Medium||StemPro MSC SFM|
|CD Hybridoma Medium||Human Endothelial-SFM||TrypLE™ Select|
|CD CHO Efficient Feed Kit||Hybridoma SFM||VP-SFM|
|CD CHO Media (1 X Concentrate)||Keratinocyte-SFM|
|CD OptiCHO™ Medium||Knockout Serum Replacement (KSR)|