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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A Partrex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Partrex, including repackagers and relabelers. The FDA regulates Partrex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Partrex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Partrex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Partrex supplier is an individual or a company that provides Partrex active pharmaceutical ingredient (API) or Partrex finished formulations upon request. The Partrex suppliers may include Partrex API manufacturers, exporters, distributors and traders.
click here to find a list of Partrex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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 Partrex Drug Master File in Japan (Partrex JDMF) empowers Partrex 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 Partrex JDMF during the approval evaluation for pharmaceutical products. At the time of Partrex 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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