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US FDA DMF (Drug Master File)
US FDA DMF (Drug Master File) is a submission with confidential information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs to the US FDA. The FDA DMF is submitted by a drug manufacturer or active and inactive material or packaging material manufacturers.
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.
FDA DMF is particularly common for APIs, and Pharma Packaging Materials. The reason, the applicant for the finished drug product references DMF in their application. This allows the FDA to review the information related to the API / Packaging material separately from the finished drug product.
Types of Drug Master File
- TYPE I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable).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 Consulting Services
- Qualified and experienced US FDA 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.
Drug Master File Submission Cost
It’s important to carefully consider these factors and develop a budget and timeline for the US FDA DMF submission process. Engaging with regulatory consultants like I3CGLOBAL initially, in the process can help estimate costs more accurately and navigate the regulatory requirements efficiently.
- US FDA DMF preparation in 2-3 months: $2500 onwards
- US Agent for FDA drug master file: $649 / Year
- eCTD Conversion: $150 / 50 pages (Discounts possible)
The cost of submitting a Drug Master File to the FDA can vary widely depending on several factors, including the complexity of the submission, the type of product or material being submitted. The manufacturer must also consider the cost of external testing in the total estimate.
US FDA DMF 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. 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