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 N1-(Pyrimidin-2-yl)sulfanilamide Drug Master File in Japan (N1-(Pyrimidin-2-yl)sulfanilamide JDMF) empowers N1-(Pyrimidin-2-yl)sulfanilamide 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 N1-(Pyrimidin-2-yl)sulfanilamide JDMF during the approval evaluation for pharmaceutical products. At the time of N1-(Pyrimidin-2-yl)sulfanilamide 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 N1-(Pyrimidin-2-yl)sulfanilamide suppliers with JDMF on PharmaCompass.