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 Amphotericinum B [INN-Latin] Drug Master File in Japan (Amphotericinum B [INN-Latin] JDMF) empowers Amphotericinum B [INN-Latin] 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 Amphotericinum B [INN-Latin] JDMF during the approval evaluation for pharmaceutical products. At the time of Amphotericinum B [INN-Latin] 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 Amphotericinum B [INN-Latin] suppliers with JDMF on PharmaCompass.