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