01 1Ningxia Qiyuan Pharmaceutical Co. , Ltd.
01 1Tetracycline hydrochloride
01 1China
Registration Number : 218MF11005
Registrant's Address : No. 1 Qiyuan Street, Wangyuan Industrial Area, Yinchuan City, Ningxia, 750101, P. R. ...
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2019-12-10
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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 Sentry av ornacycline Drug Master File in Japan (Sentry av ornacycline JDMF) empowers Sentry av ornacycline 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 Sentry av ornacycline JDMF during the approval evaluation for pharmaceutical products. At the time of Sentry av ornacycline JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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