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