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 202398_ALDRICH Drug Master File in Japan (202398_ALDRICH JDMF) empowers 202398_ALDRICH 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 202398_ALDRICH JDMF during the approval evaluation for pharmaceutical products. At the time of 202398_ALDRICH 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 202398_ALDRICH suppliers with JDMF on PharmaCompass.