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