DMF is a confidential document submitted to the US FDA, which is a complete set of documents about product chemistry, manufacturing and quality control information. The content includes general information about the product, production process, impurity studies, stability and other aspects of the data and data it provides information about the raw materials used in the production of drugs, active intermediates and their facilities, processes, packaging and warehousing.

There are five types of DMF, of which: After 2000, Type I DMF is no longer accepted by the FDA.

Type I: Organization and personnel, facilities and equipment, and standard operating procedures;

Type II: raw materials, intermediate products and their raw materials, preparation drugs;

Type III: Packaging materials — — A container;

Type IV: excipients, colorants, fragrances and raw materials thereof;

Type V: other information acceptable to FDA;

DMF is divided into two states,

“ A” =active: indicates that DMF is available and not disabled.

“ I” =Inactive: Inactive, meaning the DMF is closed by the DMF holder or FDA.

The original auxiliary package manufacturer shall submit the technical information in the form of a document to the US Food and Drug Administration (FDA) for DMF registration, and the official recommends that overseas manufacturers register DMF through the US agent, maintain contact with the FDA and handle the relevant registration matters. Registration goal: DMF registration through the administrative review of the original package to get “ A” The status of the registration number, which passes the technical review when associated with the drug preparation review, and the status of the registration number is maintained “ A” Remain the same; Among them, DMFII apis that support ANDA listing must pass the integrity review after the administrative review before they can be associated with the drug preparation for technical review.

DMF registration data is submitted in e-CTD format; Among them, Class III DMF can choose paper version and e-CTD format to submit, and the paper version will be closed in February 2022; The Electronic version of the DMF can be submitted through the FDA's Electronic Submission Gateway (ESG), and for registration data over 10GB, it can be submitted on a physical medium, such as a CD.

• United States Agent Service

• Provide DMF application data outline catalog according to relevant FDA regulations

• Gap analysis of registration data, pre-examination combined with variety information, and put forward modification suggestions to customers

• Review, translation, preparation and submission of registration materials in CTD format

• FDA review dynamic tracking, send answers to questions and submit supplementary reply materials.

• DMF number maintenance, registration information updates (including changes and annual reports).