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