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 chlorophyllin, sodium copper complex Drug Master File in Japan (chlorophyllin, sodium copper complex JDMF) empowers chlorophyllin, sodium copper complex 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 chlorophyllin, sodium copper complex JDMF during the approval evaluation for pharmaceutical products. At the time of chlorophyllin, sodium copper complex 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 chlorophyllin, sodium copper complex suppliers with JDMF on PharmaCompass.