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