Drug Master File (DMF) Guidance

Drug Master File (DMF) is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

Typically, a US DMF is filed when two or more firms work in partnership on developing or manufacturing a drug product. The DMF filing allows a firm to protect its intellectual property from its partner while complying with regulatory requirements for disclosing processing details.

The information contained in the Drug Master File may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application or amendments and supplements to any of these.

The US DMF contains factual and complete information on a drug product’s chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

Types of Drug Master File

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavour, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

We provide our service to firms that focus on developing drug master files with the United States Food & Drug Administration (FDA).

More information about the Drug Master File can be found on the FDA website.

Role of US Agents and Consultants

The major roles and responsibilities are defined below.

  • Provide a checklist containing documents to be provided by the client to the consultant for the DMP Preparation.
  • Preparation of Drug Master File for submission. (Exclusive feature)
  • Identification of records, reports, chemistry needs to furnish in the submission file(for type II DMF and III DMF).
  • Edit and organize DMF information as per FDA required format.
  • Completed FDA DMF for review and acceptance by the client.
  • Guidance on GMP.

  • Submitting DMF to FDA.( electronic or paper form)
  • Communicating with FDA on behalf of our client.
  • Assisting clients to issue LOA (letter of authorization) to FDA.
  • Annual Maintenance for the submitted Drug Master File.

  • Option 01
  • Option 02
  • eCTD converion
  • Annual Maintenance for the submitted Drug Master File.

Annual Drug Master File Maintenance service includes:

  • Respond to FDA concerns about USDMF submitted by the client.
  • Notify in advance if any changes in the submitted US FDA DMF.
  • Provide DMF changes, additions, and deletions to the FDA.
  • Submit any additional letters of authorization to the FDA.
  • Assist in the closure of a DMF on file with the U.S. FDA, as required.
  • Assistance with DMF Annual report submission to FDA.
  • Assistance in DMF Closure request submission to FDA.
  • Assistance in DMF Reactivation request submission to FDA. (for closed DMF)

Benefits of Drug Master File Number

The following are the major benefits

  • Gives you an edge over your competitors.

  •  Adds prestige to your company and product

  • Confidence building with customers

  • Improve sales anywhere in the world

  • Penetrating high entry barrier US market.

DMF Pricing

Service available from Bangalore, India and Chicago, USA.

DMF Type Description Fee
Type 11 Drug substance/intermediates and material used in their manufacture $ 3700 – $ 4500
Type 111 Drug Packaging Materials and products $ 3200
Type 1V Drug / Pharma Excipients $ 3800
US Agent Service $ 649 annually

 

Note:

  • GMP GAP analysis and Implementation will be separately invoiced as per the agreed terms and conditions.
  • Travelling and Lodging additional.
  • eCTD conversion charges depending on the number of pages (for ex;100 pages 500 USD
  • Payment – 50 % advance and balance after submission.
  • Method of communication – Telephone & Skype
  • Documentation by using an external Cloud server.
  • Minimum Timeline – 30 Days.
  • Tax’s Applicable as per Govt. rules.