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