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