01 1HANMI FINE CHEMICAL CO. , LTD.
01 1Sterile cefotaxime sodium
01 1South Korea
Registration Number : 224MF10209
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2012-10-29
Latest Date of Registration : 2013-10-23
A Cefotaxime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefotaxime, including repackagers and relabelers. The FDA regulates Cefotaxime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefotaxime 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 Cefotaxime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefotaxime supplier is an individual or a company that provides Cefotaxime active pharmaceutical ingredient (API) or Cefotaxime finished formulations upon request. The Cefotaxime suppliers may include Cefotaxime API manufacturers, exporters, distributors and traders.
click here to find a list of Cefotaxime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Cefotaxime Drug Master File in Japan (Cefotaxime JDMF) empowers Cefotaxime 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 Cefotaxime JDMF during the approval evaluation for pharmaceutical products. At the time of Cefotaxime 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 Cefotaxime suppliers with JDMF on PharmaCompass.
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