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