01 1Zhejiang Ausun Pharmaceutical Co. , Ltd.
01 1Sitafloxacin hydrate
01 1China
Registration Number : 228MF10177
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2016-08-29
Latest Date of Registration : 2024-06-12
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A sitafloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sitafloxacin, including repackagers and relabelers. The FDA regulates sitafloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sitafloxacin 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 sitafloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A sitafloxacin supplier is an individual or a company that provides sitafloxacin active pharmaceutical ingredient (API) or sitafloxacin finished formulations upon request. The sitafloxacin suppliers may include sitafloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of sitafloxacin 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 sitafloxacin Drug Master File in Japan (sitafloxacin JDMF) empowers sitafloxacin 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 sitafloxacin JDMF during the approval evaluation for pharmaceutical products. At the time of sitafloxacin 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 sitafloxacin suppliers with JDMF on PharmaCompass.
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