| Drug Master File |
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Drug Master File or DMF refers to a set of documents presented to FDA by a pharmaceutical manufacturer. This file contains information that may be confidential for the company but is necessary for presenting to the regulatory authority.
Information, often contains details to facilitate understanding of the product, processes, systems, facility, articles and equipments used in manufacturing process, quality control and assurance, storage and distribution.
Although the DMF is not a mandatory file, a pharmaceutical manufacture submits this file to support their export application or New Drug Application or Investigational New Drug Application or Abbreviated New Drug Application.
A DMF, however, is not a substitute for any of these applications. DMFs are of five types: Type 1 through Type V and each should contain one kind of information and supporting data.
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