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 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE Drug Master File in Japan (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE JDMF) empowers DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE 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 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE JDMF during the approval evaluation for pharmaceutical products. At the time of DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE 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 DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE suppliers with JDMF on PharmaCompass.