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