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