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