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 Carbamex 330mgms Drug Master File in Japan (Carbamex 330mgms JDMF) empowers Carbamex 330mgms 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 Carbamex 330mgms JDMF during the approval evaluation for pharmaceutical products. At the time of Carbamex 330mgms 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 Carbamex 330mgms suppliers with JDMF on PharmaCompass.