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 Nitroglycerin, solution in alcohol, with >1% but not >5% nitroglycerin [UN3064] [Flammable liquid] Drug Master File in Japan (Nitroglycerin, solution in alcohol, with >1% but not >5% nitroglycerin [UN3064] [Flammable liquid] JDMF) empowers Nitroglycerin, solution in alcohol, with >1% but not >5% nitroglycerin [UN3064] [Flammable liquid] 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 Nitroglycerin, solution in alcohol, with >1% but not >5% nitroglycerin [UN3064] [Flammable liquid] JDMF during the approval evaluation for pharmaceutical products. At the time of Nitroglycerin, solution in alcohol, with >1% but not >5% nitroglycerin [UN3064] [Flammable liquid] 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 Nitroglycerin, solution in alcohol, with >1% but not >5% nitroglycerin [UN3064] [Flammable liquid] suppliers with JDMF on PharmaCompass.