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