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 AKOS005145900 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AKOS005145900, including repackagers and relabelers. The FDA regulates AKOS005145900 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AKOS005145900 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A AKOS005145900 supplier is an individual or a company that provides AKOS005145900 active pharmaceutical ingredient (API) or AKOS005145900 finished formulations upon request. The AKOS005145900 suppliers may include AKOS005145900 API manufacturers, exporters, distributors and traders.
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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 AKOS005145900 Drug Master File in Japan (AKOS005145900 JDMF) empowers AKOS005145900 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 AKOS005145900 JDMF during the approval evaluation for pharmaceutical products. At the time of AKOS005145900 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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