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