This is an overview of Type II DMF and API.
Drug Master File (DMF) is used to provide confidential and detailed information about facilities, and processes used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is not a substitute for any Drug Application, or Export Application. It is not approved or disapproved. Technical content of a DMF submission is reviewed only in connection with the review of a Drug Application, or an Export Application. The DMF usually covers the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product, for example, drug substance, excipient, packaging material. There are five types of DMFs: Among five different types of DMF’s, Type II is for Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Beginning May 5, 2018, the United States Food and Drug Administration (USFDA) mandated that the new DMFs as well as documentation for existing DMFs must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected.
A DMF fee is only due and a Completeness Assessment performed if the material in the DMF is an API (Active Pharmaceutical Ingredient) and you intend for it to be referenced in a generic drug submission (i.e. ANDA). If you need to pay the fee then you should get a pre-assigned DMF number and then submit all modules of the DMF when they are ready. The pre-assigned number is sufficient to pay the fee but we would not be able to perform a Completeness Assessment until the entire DMF were submitted.
https://www.fda.gov/drugs/drug-master-files-dmfs/types-drug-master-files-dmfs
Please also check this link Generic Drug User Fee Amendments (GDUFA) that includes provisions for DMF fees, a completeness assessment, and communications with DMF holders for Type II DMFs for drug substances (active pharmaceutical ingredients (APIs)) used to support ANDAs. These provisions do not apply to other types of DMFs or to Type II DMFs used to exclusively support NDAs or INDs. For more information about GDUFA as it relates to Type II DMFs, see:
- DMF enhancements under GDUFA II
- Completeness Assessments for Type II API DMFs Under GDUFA (guidance for industry)
A completeness assessment is a series of questions that must be satisfied for a DMF to be made publicly available on FDA’s website. It does not replace the full scientific review to determine the adequacy of a DMF to support an ANDA regulatory action. - List of Type II DMFs Available for Reference
A list of DMFs that have passed the completeness assessment and are available for reference by ANDAs under GDUFA. - Here is the updated List of DMF’s: List of Drug Master Files (DMFs)
Acheve Technology, Inc. has been successfully submitted eCTD for DMF’s in the last five year and would like to help you to complete your eCTD submission of DMF’s.