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