A Drug Master File (DMF) is a confidential, detailed document submitted to the U.S. Food and Drug Administration (FDA). It provides extensive information regarding the facilities, processes, and components involved in the manufacturing, processing, packaging, and storing of one or more human pharmaceuticals.
The key feature of Drug Master File (DMF):
- Confidential: DMF content is accessible only to the FDA and authorized parties.
- Voluntary: Submitting a DMF is recommended for transparency but not legally required.
- Assessment Only: The FDA evaluates DMFs when referenced, without approving them.
Why Drug Master File (DMF) is Important?
- DMFs enable companies to maintain confidentiality of sensitive data, such as manufacturing processes or formulation details, while providing essential technical information to the FDA.
- Drug Master Files (DMFs) are utilized by companies that produce Active Pharmaceutical Ingredients (APIs), excipients, or packaging materials to demonstrate quality and compliance without revealing proprietary information.
- When a manufacturer references a supplier’s DMF, the FDA can review it without resubmission, streamlining the review of:
- New Drug Applications (NDAs)
- Abbreviated New Drug Applications (ANDAs)
- Investigational New Drug applications (INDs)
- Enhances Supply Chain Transparency: DMFs help the FDA verify third-party component quality, ensuring product safety and integrity.
What are the Modules or sections for DMF
A Drug Master File (DMF) submitted to the U.S. Food and Drug Administration (FDA) conforms to the Common Technical Document (CTD) format, which categorizes information into specific modules or sections. This standardized structure streamlines the review process and ensures consistency across all submissions.
📦 CTD Modules in a DMF:
âś… Module 1: Administrative and Product Information
- Cover letter
- FDA forms
- Application number
- Letter of authorization (LOA)
- DMF Holder and Agent Information
âś… Module 2: Overview and Summaries
- Quality Overall Summary (QOS)
- Introduction to the DMF
- Body of Data Summary
✅ Module 3: Quality (Chemistry, Manufacturing, and Controls – CMC)
| Section | Content |
| 3.2.S | Drug Substance (for Type II DMFs) |
| 3.2.S.1 | General Information (INN name, structure, etc.) |
| 3.2.S.2 | Manufacture (manufacturer, synthesis, process controls) |
| 3.2.S.3 | Characterization (impurities, structure elucidation) |
| 3.2.S.4 | Control of Drug Substance (specifications, testing methods) |
| 3.2.S.5 | Reference Standards or Materials |
| 3.2.S.6 | Container Closure System |
| 3.2.S.7 | Stability (stability studies and data) |
Other Modules (like 4 and 5, which relate to nonclinical and clinical data) are not required for DMFs, because DMFs typically support chemistry and manufacturing information—not efficacy or safety data.
Other Information and Fees for Submission of DMF
No Fee for Initial Drug Master File (DMF) Submission
- For Type III, IV, and V DMFs, and
- For Type II DMFs not referenced in an ANDA,
- There is no filing fee required by the FDA.
Fee Required for Type II DMFs Referenced in ANDAs
| Category | Fee Type | 2025 Amount (Estimated)* |
| Type II DMF | One-time DMF Fee (when referenced in an ANDA) | ~$80,000–$90,000 USD |
- The fee must be paid before the DMF can be referenced in an ANDA.
- Only one-time per DMF, not per referencing application.
*Fees are updated annually by the FDA under the GDUFA (Generic Drug User Fee Amendments).
- Drug Master File (DMF) holders must submit an annual update on the yearly of the original submission.
- Fee is not required for DMFs used in NDAs, INDs, or BLAs unless referenced in an ANDA.
- A Letter of Authorization (LOA) must accompany the referencing application.
How Medwisdom Lifesciences can assist you with eCTD-DMF Dossier?
The Medwisdom Lifesciences assist in the following
- Comprehensive Review of DMF Documentation
> Technical and regulatory review of the DMF
> Recommendations and gap analysis
> Review report with corrective actions - Preparation and Submission of DMF to US-FDA
> Formatting as per FDA eCTD requirements
> Electronic submission via ESG
> US Agent coordination (if required) - Post-Submission Support
> Response to US-FDA queries (Generally no query on DMF submission, but if ANDA is submitted with respect to This DMF number, then query may raise).
FAQs:
1. Who Needs DMF Preparation Services?
- API Manufacturers: Companies that manufacture Active Pharmaceutical Ingredients (APIs) or intermediates. They need Type II DMFs to supply U.S. drug makers or generic companies.
- Excipients and Additives Manufacturers: Manufacturer providing inactive ingredients such as binders, colorants, Flavors, etc. These typically require a Type IV DMF.
- Packaging Material Manufacturers: Companies that produce primary packaging materials (e.g., blister packs, caps, bottles). Must submit a Type III DMF if their materials are used in drug products.
2. What Is the Timeline for Preparation of DMF/eCTD-DMF?
- DMF Technical Review: 2 to 5 days
- eCTD-DMF Submission: Within 5 working days post-approval of final version of CTD (Conversion of eCTD and Portal submission)
3. What Is the Consultancy/Professional charges for DMF/eCTD-DMF?
For Quotation, kindly share the product list on the mail id: info@medwisdom.in
4. What happens if the DMF is incomplete or outdated?
The referencing application may be delayed or rejected. It’s the DMF holder’s responsibility to keep it up to date.
