The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The AGN-PC-0JKH4Z Drug Master File in Japan (AGN-PC-0JKH4Z JDMF) empowers AGN-PC-0JKH4Z API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the AGN-PC-0JKH4Z JDMF during the approval evaluation for pharmaceutical products. At the time of AGN-PC-0JKH4Z JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of AGN-PC-0JKH4Z suppliers with JDMF on PharmaCompass.