Japanese Drug Master Files (JDMF) Database:
Drug master files are submissions to FDA used to provide confidential, comprehensive details about manufacturing facilities, processes used, or materials and methods applied in the manufacturing, processing, packaging, and storing of pharmaceutical drug products. The Drug Master File (DMF) is called Master File (MF) In Japan.
Finished dosage formulation (FDF) Supplier: Finished dosage formulations (FDF) Suppliers manufacture finished dosage formulation (FDF) or they buy from the manufacturers and resell it to final consumers.
Information regarding the following Items is required for Japanese Drug Master Files (JDMF) registration:
The requirement for Japanese Drug Master Files (JDMF) application holder:
Master File application is not accepted if it has the following conditions.
Drug master files are submissions to FDA used to provide confidential, comprehensive details about manufacturing facilities, processes used, or materials and methods applied in the manufacturing, processing, packaging, and storing of pharmaceutical drug products. The Drug Master File (DMF) is called Master File (MF) In Japan.
Items registered in Japanese Drug Master File (JDMF) will be considered as the part of information which should be described in an approval application form and the documents attached with it. It is important for the Drug Master File Holder, the domestic country caretaker and related personnel to follow the Japanese pharmaceutical laws (Pharmaceutical Affairs Law) and the regulations. The MAA/MAH MAA/MAH, the Japanese Drug Master File (JDMF) holder and the domestic country caretaker are required to have the proper communication with each other.
Chemxpert provides data regarding DMF of various countries as under
For example: Chemxpert has 14 Japanese Drug Master Files (JDMF) for paracetamol.