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