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