Drug Master Files
CellGenix has submitted Drug Master Files (DMF) for many of our products to the US Food and Drug Administration (FDA) to support our US customer’s submissions to the FDA.
Please note that cross reference is only possible for the US-FDA in combination with an IND, BLA, NDA or ANDA application of our customers. To date, no comparable DMF System for biological active substances is in place in Europe.
DMF General Idea
A Drug Master File (DMF) is a regulatory instrument to provide confidential detailed information about the manufacturing conditions of drugs or biologics for use in humans or animals. Manufacturers can submit this document to the FDA. It enables the manufacturer to protect its intellectual property by allowing the FDA to review the information in support of a third party’s submission.
The DMF contains confidential information on a drug product's chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging. This information 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.
The FDA has access to records only in conjunction with a letter of authorization permitting FDA to reference the DMF. To initiate the cross reference authorization of a CellGenix DMF, please submit a letter of authorization request to CellGenix requesting that we provide a DMF letter of authorization to the respective FDA center. After we received your request, we will advise the FDA that they have our approval to make a CellGenix Drug Master File part of your submission.
CellGenix Cell Processing Reagents with DMFs
CellGenix DMFs are Type II DMFs which are classified as "Material" used in the preparation of a drug or drug product.
Active CellGenix Drug Master Files are currently:
- DC Medium
CellGenix is aimed at providing Drug Master Files for all media and cytokines in the long term. On that account there are continuously Drug Master Files under development.
To submit a letter of authorization request please contact our US office:
One New Hampshire Avenue, Suite 125
Portsmouth, NH 03801, USA
Phone: 603 373 0408
Fax: 603 373 8104