US FDA Drug Master File
Drug Master File is a confidential document submitted voluntarily to the FDA by human drug manufacturers, processors, packagers, and stores. FDA DMF contains information about production facilities, processes, packaging, quality control, and storage products
Drug Master File is generally submitted by manufacturers of Active Pharmaceutical Ingredient (API), Drug Substance, Drug Intermediate Substance, and Drug Packaging Material.
FDA DMF usually contains the components/ingredients, chemistry, process technology, quality controls either of 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.
Types of Drug Master Files
- TYPE I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).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.
US FDA DMF Fees.
- DMF Preparation in 2-3 months : $ 2500 on wards
- US Agent for DMF : $ 649 / Year
- eCTD Conversion : $ 150 / 50 pages ( Discounts possible)
Role of Consultants & US FDA Agents
- Qualified and experienced Consultants.
- One-stop solution for US Agents 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.
Drug Master File Contents
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
- 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
- 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