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