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Drug Master File

US FDA DMF (Drug Master File)

Drug Master File (US FDA DMF) usually contains the components or ingredients, chemistry, process technology, and quality controls for either the drug substance, excipient, or packaging material. Drug master file has a significant role in finished product drug applicants’ NDAs, ANDAs, and INDs. So, careful preparation of files by an expert is highly essential for successful submission.

Drug Master File Types

  • TYPE I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).
  • TYPE II: Drug products or substances or intermediate and or materials used for drug preparation.
  • TYPE III: Packaging Material.
  • TYPE IV: Excipient or Colorant or Flavor/Essence or material used in the Preparation.
  • TYPE V: FDA Accepted Reference Information.

Drug Master File Preparation Cost

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

  • Qualified and experienced US DMF consultants.
  • One-stop solution for US FDA Agent and documentation.
  • Submission & US Agent Service from US Office.
  • The experienced hand does a final review of files before FDA submission.
  • Dedicated office staff to address FDA queries on behalf of the client.
  • eCTD conversion and submission.
  • Data security and privacy.

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. US DMF 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