Services to Ease FDA Regulatory Compliance

FAQ: DRUG MASTER FILE

What is FDA DMF ? US FDA DMF Filing

FDA DMF   filing requirements (Drug Master File) DMF stands for Drug Master File which contains confidential information related to the manufacturing, control  or chemistry of the product.  A US DMF filing is the provision made by the US FDA  to maintain the confidentiality  of the information in the DMF Filing. The Manufacturer of the Drug, … Continue reading What is FDA DMF ? US FDA DMF Filing

What should you know about DMF annual report

In the  industry there  is  lot of confusion  about  content and format of   DMF  annual report. Important  –  DMF annual reports are  NOT used for   reporting changes in the drug master file. Amendments  are used for reporting changes in the DMF. Contents of  DMF annual report.  1.Cover letter – Annual report should contain the  formal … Continue reading What should you know about DMF annual report

How much is the DMF Fee ?

DMF fee is applicable only for type II DMFs  (API or Drug  Substance).  There is no fee charged by FDA for packing material or excipient DMF. FY 2019 , DMF fee is     $ 55,013.   This fee should be paid well before referencing your DMF in your ANDA application. However, you can still submit the … Continue reading How much is the DMF Fee ?

How much time is required for DMF submission?

The timeline for the DMF submission depends on the availability of technical documents. If you have all the documents – including Batch records, Specification, Method of analysis, In process specification, Raw material specification and testing reports, Impurity profiling, Batch analysis data, and stability study – it will take about 10 working days to compile the … Continue reading How much time is required for DMF submission?

How we can assist for DMF submission to FDA?

Pragmatic offers a complete solution for all types of DMF submission to the FDA. We offer DMF review, compilation, technical gap analysis, eCTD conversion and submission through ESG. We also provide services for management throughout the lifecycle of a drug master file. Please contact us for more information.

What is a Drug Master File?

A Drug Master File – or DMF – is FDA’s provision to submit confidentiality information on the chemistry, manufacturing and control information about a product for the agency’s evaluation.

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