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 Idrazide dell'acido isonicotinico Drug Master File in Japan (Idrazide dell'acido isonicotinico JDMF) empowers Idrazide dell'acido isonicotinico 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 Idrazide dell'acido isonicotinico JDMF during the approval evaluation for pharmaceutical products. At the time of Idrazide dell'acido isonicotinico 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 Idrazide dell'acido isonicotinico suppliers with JDMF on PharmaCompass.