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