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