The main types of DMF are:
The first category, production location, factory facilities and personnel (cancelled);
The second category, intermediates, APIs and drugs;
The third category, packaging materials;
The fourth category, auxiliary materials, colorants, spices, essences and other additives;
Type V, non-clinical data and clinical data.
Although the US FDA does not stipulate in official documents that manufacturers exporting to the United States must report DMF information, if the product is used as a prescription drug, the US FDA will send officials to inspect the manufacturer to determine whether the production of the factory is consistent with the reported information and whether it is produced according to the requirements of cGMP (current GMP) in the United States. The DMF document library in the United States is a supplier resource library, which is widely referenced by pharmaceutical companies all over the world, so almost all pharmaceutical companies that want to push their products to the international market have DMF for filing. DMF has the following advantages after registration:
1 simplifies the application content of preparation manufacturers, and directly replaces the specific information of relevant units in the preparation application materials with DMF record number, thus reducing the risk of enterprise technical secret disclosure caused by providing information to many preparation customers;
2. Enterprises and their products with DMF filing number will be publicized on the FDA website. Holding the DMF record number given by FDA can attract more preparation customers to establish cooperative relations, and be given priority by preparation customers in the enterprise competition;