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 Gd-HP-D03A Drug Master File in Japan (Gd-HP-D03A JDMF) empowers Gd-HP-D03A 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 Gd-HP-D03A JDMF during the approval evaluation for pharmaceutical products. At the time of Gd-HP-D03A 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 Gd-HP-D03A suppliers with JDMF on PharmaCompass.