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