A Drug master File (US 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 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 disclosure of processing details.
The information contained in the DMF 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 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.
In United States there are 5 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, Flavor, Essence, or Material Used in Their Preparation|
|Type V||FDA Accepted Reference Information|
We provide our service to firms focuses on the development of drug master files with the United States Food & Drug Administration (FDA).
Our DMF Submission Scope.
Option 01 Documentation and Technical Consultancy.
Option 02 U.S Agent Service
Our Annual DMF Maintenance service includes…..
Benefits of DMF submission
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