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