USFDA DMF (Drug Master Files) are submissions made to USFDA for human drug products which provide confidential and detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing.
The DMF are required to be submitted in eCTD formats with exception of type III DMF. The DMF are not required by the regulation. DMFs are neither approved nor rejected.
Your Drug Master File’s technical sections will be reviewed by USFDA with reference to the drug applications (IND/NDA/ANDA etc.).
DMF shall be formed based on the regulation 21 CFR 314.420.
Below link can be looked into for the various list of DMF received by FDA. This database is updated on quarterly basis.
You will be able to review the details as per below table –
|0||I||II||DD/MM/YYYY||ABC XYD CO.||#DRUGNAME#|
|DMF Type||Information Included|
|Type II||Drug substances and intermediates, the materials involved in their manufacturing or Drug Product|
|Type III||Packaging material|
|Type IV||Excipients, Colorants, Flavors, Essence, or Material Used in Their Preparation|
|Type V||Reference information accepted by the FDA|
US FDA accepts DMF in Electronic format. The e-submissions will have a pre-assigned number. The pre-assigned number can be requested via email.
Restricted part (Closed Part) or also called as Confidential Part
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