We have submitted Drug Master Files (DMF) to the US Food and Drug Administration (FDA) CBER for most of our GMP grade products to support our US customers’ submissions to the FDA.
The DMF contains confidential information on a product’s chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging. This information may be used to support an Investigational New Drug (IND) application, Biologic License Application (BLA), New Drug application (NDA) or Abbreviated New Drug Application (ANDA), another DMF, an export application or amendments to any of these.
Please note that cross reference by the FDA is only possible in combination with an IND, BLA, NDA or ANDA application. To date, no comparable DMF System for biological raw materials is in place in Europe.
Sartorius CellGenix DMFs are Type II DMFs which are submitted in Electronic Common Technical Document (eCTD) format.
The FDA only has access to a DMF in conjunction with a letter of authorization that permits the FDA to reference the DMF. You can initiate a cross reference authorization for a Sartorius CellGenix DMF by submitting a letter of authorization request. After receiving your request, we will inform the FDA that they have our approval to include the Sartorius CellGenix DMF in your FDA submission.
We currently offer DMFs for the following products: