01 3Amicogen (China) Biopharm Co. , Ltd.
02 1Fujian Fukang Pharmaceutical Co. , Ltd.
01 3Cefmetazole
02 1cefmetazole acid
01 4China
Registration Number : 305MF10064
Registrant's Address : No. 1688 Shixian Road, Jining City, Shandong Province
Initial Date of Registration : 2023-05-17
Latest Date of Registration : 2024-12-25
Registration Number : 231MF10089
Registrant's Address : No. 1688 Shixian Road, Jining City, Shandong Province
Initial Date of Registration : 2019-04-11
Latest Date of Registration : 2019-04-11
Registration Number : 229MF10137
Registrant's Address : No. 6, Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, Fujian, China
Initial Date of Registration : 2017-07-24
Latest Date of Registration : 2017-07-24
Registration Number : 227MF10099
Registrant's Address : No. 1688 Shixian Road, Jining City, Shandong Province
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2015-04-09
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A Pharmacia Brand of Cefmetazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pharmacia Brand of Cefmetazole Sodium, including repackagers and relabelers. The FDA regulates Pharmacia Brand of Cefmetazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pharmacia Brand of Cefmetazole Sodium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pharmacia Brand of Cefmetazole Sodium supplier is an individual or a company that provides Pharmacia Brand of Cefmetazole Sodium active pharmaceutical ingredient (API) or Pharmacia Brand of Cefmetazole Sodium finished formulations upon request. The Pharmacia Brand of Cefmetazole Sodium suppliers may include Pharmacia Brand of Cefmetazole Sodium 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 Pharmacia Brand of Cefmetazole Sodium Drug Master File in Japan (Pharmacia Brand of Cefmetazole Sodium JDMF) empowers Pharmacia Brand of Cefmetazole Sodium 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 Pharmacia Brand of Cefmetazole Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Pharmacia Brand of Cefmetazole Sodium 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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