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