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