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 UNII-PDC6A3C0OX Drug Master File in Japan (UNII-PDC6A3C0OX JDMF) empowers UNII-PDC6A3C0OX 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 UNII-PDC6A3C0OX JDMF during the approval evaluation for pharmaceutical products. At the time of UNII-PDC6A3C0OX 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 UNII-PDC6A3C0OX suppliers with JDMF on PharmaCompass.