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 alpha-(Trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene)), mixture with silicon dioxide Drug Master File in Japan (alpha-(Trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene)), mixture with silicon dioxide JDMF) empowers alpha-(Trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene)), mixture with silicon dioxide 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 alpha-(Trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene)), mixture with silicon dioxide JDMF during the approval evaluation for pharmaceutical products. At the time of alpha-(Trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene)), mixture with silicon dioxide 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 alpha-(Trimethylsilyl)-omega-methylpoly(oxy(dimethylsilylene)), mixture with silicon dioxide suppliers with JDMF on PharmaCompass.