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