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 Diazepam 1000 microg/mL in Methanol Drug Master File in Japan (Diazepam 1000 microg/mL in Methanol JDMF) empowers Diazepam 1000 microg/mL in Methanol 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 Diazepam 1000 microg/mL in Methanol JDMF during the approval evaluation for pharmaceutical products. At the time of Diazepam 1000 microg/mL in Methanol 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 Diazepam 1000 microg/mL in Methanol suppliers with JDMF on PharmaCompass.