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