Abbreviated as Drug Master File. DMF is a master file which is produced by the pharmaceutical manufacturers to the appropriate regulatory authorities or Food and Drug Administration(FDA) which intends for drug marketing.While manufacturing, processing, packaging and storing of human drugs, it provides all the confidential information in details like articles, processes or facilities. Usually, DMF is produced when there is a partnership between two firms to manufacture a human drug. DMF protects intellectual property from the other firms it works with or say partner for disclosure or processing details while complying with regulatory requirements.
DMF Types :
There are five types of DMF Types – Type I to V, the most common being Type II followed by Type III. Type I is not in the process presently. It is not accepted by Food and Drug Authorities (FDA). All other types from Type II to Type V are actively submitted.
This is not acceptable by regulatory authorities. Though, the older ones remained in the files.
This type contains the Active Pharmaceutical Ingredient. Drugs of dosage form manufactured by different companies which can file an Abbreviated New Drug Application (ANDA) are also used in this type. Manufacturing section, Quality controls, Validations, stability data, Impurities, Packaging and labeling, raw materials, Intermediates and In-process and finished drug substances are all included in this type.
Bottles and caps which come under packaging materialsor even PVC resin should be covered in FDA documents like NDA and DMF. Uses of package materials, its components, and compositions, Name of the suppliers of the components used in packaging materials are included in this type.
colorant and flavor which is used in children drugs, the inactive substance called excipients which are used to bind the drug powder to make a tablet, all come under this type of DMF.
All information which are not included in other DMFs are used here.
Why Tammina Life Science –
There is no legal requirement to file a DMF. An Investigational New Drug (IND)/ New Drug Application (NDA)/ Abbreviated New Drug Application (ANDA) support the details contained in DMFs. But DMF isn’t a substitute to any of them. Central Document Room (CDR) staff reviews DMF for administrative purpose. DMF does not come under regulatory purpose. It is not mandatory to file a DMF. Tech Tammina Life Science experts maintain the life cycle of DMFs. Update and amend existing DMFs with the United States Food and Drugs Administration (USFDA). We create baseline submission for paper DMFs. We format documents according to USFDA. Tammina Life Science experts request for pre-assigned application number eCTD submissions on behalf of API manufacturer.