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