What is US DMF ( Drug Master File ) Submission ?
US DMF or Drug Master File submission is a submission you make to the US Food and Drug Administration (FDA). This submission will be used to provide confidential detailed information about facilities, articles or processes used in the manufacturing, processing, packaging, and storing of one or more human drugs.
The US FDA issues a DMF number to each submission. This number is used to identify your DMF Application with FDA and further referencing in IND- Investigational New Drug , NDA- New Drug Application and ANDA Abbreviated New Drug Applications
Who can apply or submit Drug Master File for US DMF Number ?
Manufacturers of
- Active Pharma Ingredients – Bulk Drug Manufacturer
- Drug Intermediate
- Excipients
- Pharmaceutical Primary Packing Material
- Sterilization and Filing Facilities
can generally apply for US DMF by submitting a Drug Master File to US FDA. Information shared in DMF Application is kept confidential by FDA and the same is not disclosed in public.
Drug Master File ( DMF ) play a critical part in approval of Investigational New Drug Application (IND), New Drug Application (NDA), and an Abbreviated New Drug Application (ANDA) hence information provided in DMF has to be carefully drafted by an Expert.
What are the different types of US DMF ?
- TYPE I – Obsolete NO longer accepted by FDA
- TYPE II – Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product
- Type III – Packaging Material -eg Bottles, Films, Vials, Ampoules etc
- Type IV – Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V – FDA-Accepted Reference Information – Eg Gamma Radiation Plants, ETO, Facility Related Information etc
Where can i see Drug Master File - US DMF List ?
US FDA maintains a Public Database of all Drug Master File filled with US FDA, anyone can access this database from the below Link which will downloads an excel file
USFDA updates the List every Quarter , the above link is for quarter ending 31st March 2023.
US DMF List has Status of every DMF with Abbreviation Denoting A= Active and I= In Active
How can FDApals help you with Drug Master File Submission ?
We at FDApals can assist you to fulfil your DMF Submission requirements with ease. Having over 30 years of experience in the field of regulatory filings and filed 500+ DMFs we can help you
- Draft Complete DMF from Scratch
- Gap Audit your existing DMF/ Documents
- eCTD Conversion and Submission to FDA
- Identify Testing requirements
- US Agent Services for FDA
- Annual Report / Amendment Submission to FDA / Issuing LOAs