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