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