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 Urisec 22% Crm Drug Master File in Japan (Urisec 22% Crm JDMF) empowers Urisec 22% Crm 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 Urisec 22% Crm JDMF during the approval evaluation for pharmaceutical products. At the time of Urisec 22% Crm 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 Urisec 22% Crm suppliers with JDMF on PharmaCompass.