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 Glycol 6000, Polyethylene Drug Master File in Japan (Glycol 6000, Polyethylene JDMF) empowers Glycol 6000, Polyethylene 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 Glycol 6000, Polyethylene JDMF during the approval evaluation for pharmaceutical products. At the time of Glycol 6000, Polyethylene 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 Glycol 6000, Polyethylene suppliers with JDMF on PharmaCompass.