Instant Report
FDF

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.

  • In order to apply for Japanese Drug Master Files (JDMF) registration, manufacturers from foreign countries must appoint a domestic caretaker for APIs, excipients etc.
  • It is used to protect the expertise of API manufacturing techniques from the marketing authorization applicant (MAA) or marketing authorization holder (MAH) of pharmaceutical drugs.
  • As per the law Registration in the Master File is not mandatory.
  • Items registered in the Master File are cited as mandatory information for the review.

Information regarding the following Items is required for Japanese Drug Master Files (JDMF) registration:

  • Information for Active Pharmaceutical Ingredients (API) & Pharmaceutical intermediates.
  • Information for novel excipients & combination of excipients which have different composition ratios from the existing composition ratios.
  • Information for materials used to develop Cellular & drugs based on tissues
  • Others materials

The requirement for Japanese Drug Master Files (JDMF) application holder:

Master File application is not accepted if it has the following conditions.

  • If the manufacturers are only following the process of packing, repackaging, labelling, storing, investigation.
  • If there is a combination of Customer and Contract Manufacturer.

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

  • USMF
  • JDMF
  • KDMF

For example: Chemxpert has 14 Japanese Drug Master Files (JDMF) for paracetamol.