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