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 Ethanolum (96 per centum) Drug Master File in Japan (Ethanolum (96 per centum) JDMF) empowers Ethanolum (96 per centum) 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 Ethanolum (96 per centum) JDMF during the approval evaluation for pharmaceutical products. At the time of Ethanolum (96 per centum) 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 Ethanolum (96 per centum) suppliers with JDMF on PharmaCompass.