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