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    US FDA DMF (Drug Master File)

    US FDA DMF (Drug Master File) is a confidential document submitted voluntarily to the FDA by human drug manufacturers, processors, packagers, and storers.


    FDA DMF contains information about production facilities, processes, packaging, quality control, and storage products.


    FDA DMF is generally submitted by manufacturers of Active Pharmaceutical Ingredient (API), Drug Substance, Drug Intermediate Substance, and Drug Packaging Material.


    US FDA Drug Master File usually contains the components/ingredients, chemistry, process technology, quality controls either of drug substance, excipient or packaging material.


    FDA DMF’s have a significant role in finished product drug applicants NDAs, ANDAs, and INDs. So, careful preparation of files by an expert is highly essential for the successful submission.

    US Drug Master File(s) Types

    Following are the FDA DMF file types:

    1. Type I
      Manufacturing Site, Facilities, Operating Procedures, and Personnel (FDA Removed and no longer applicable)
    2. Type II
      Drug products or substance or intermediate and or materials used for the preparation of any of the above.
    3. Type III
      Packaging Material
    4. Type IV
      Excipient or Colorant or Flavor/Essence or material used in the Preparation
    5. Type V
      FDA Accepted Reference Information

    US Drug Master File and Pricing

    The following are the fees charged for various FDA DMF services.

    • DMF Preparation in 2-3 months : $ 2500 on wards
    • US Agent for DMF : $ 649 / Year
    • eCTD Conversion : $ 150 / 50 pages ( Discounts possible)

    Drug Master File Format

    US FDA accepts drug master files in Electronic format. The e-submissions will be having a pre-assigned number but this pre-assigned number is not required when data is converted to paper to electronic format from paper.


    A 6-digit must be submitted as 00XXXX with the old number while converting it into electronic format initially.


    DMFs may be submitted following the format recommended in the Common Technical Document (CTD).


    A. Restricted part (Closed Part) or also called as Confidential Part

    • Manufacturer
    • Manufacturing facility and GMP
    • Description of the manufacturing process and process controls
    • Control of materials
    • US Agent appointment and authorization
    • Owner/operator contact information


    B. Applicant’s part (Open Part) or also called a Non-confidential part.

    • General information
    • Specification
    • Control of critical steps and intermediates
    • Process validation and/or evaluation
    • Manufacturing process development
    • Material Characterization
    • Quality Control
    • Reference standards or materials
    • Container closure system
    • Stability
    • Shelf-life

    Role of Consultants

    Role of US FDA Agent

    • Qualified and experienced staffs.
    • Dedicated office staffs to address FDA queries on behalf of the client.
    • eCTD conversion and submission.
    • Data security and privacy.