Report Type: Industry Trends
Report Category: Regulatory Insights
Report Subcategory: Drug Master Files (DMF)
Date: February 2022
Drug Master Files (DMF): Drugs, Companies, News, Deals, Patents, Drug Sales & Forecast, Future Events, DMF, Manufacturing
A Drug Master File (DMF) is a type of submission made to the US Food and Drug Administration (FDA), EMEA, PMDA & KFDA to provide important information related to facilities, processes or ingredients used for manufacturing, packaging or storing of any human drugs. Though it is not mandatory to file a DMF, the submission is subject to the discretion of the manufacturer. DMFs are generally filed to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), any other DMF, application of export, or to support any of these.
Report covers 14,000+ Active DMFs from US FDA, EMEA, PMDA & KFDA. Data connected with respective generic approvals, patents and drug sales and estimates.
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