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 ALBUTEROL SULFATE [USP MONOGRAPH] Drug Master File in Japan (ALBUTEROL SULFATE [USP MONOGRAPH] JDMF) empowers ALBUTEROL SULFATE [USP MONOGRAPH] 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 ALBUTEROL SULFATE [USP MONOGRAPH] JDMF during the approval evaluation for pharmaceutical products. At the time of ALBUTEROL SULFATE [USP MONOGRAPH] 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 ALBUTEROL SULFATE [USP MONOGRAPH] suppliers with JDMF on PharmaCompass.