01 1DongKook Life Science Co. , Ltd.
01 1Gadoteridol
01 1South Korea
Registration Number : 225MF10175
Registrant's Address : 4F, 16, Teheran-ro 114-gil, Gangnam-gu, Seoul, Korea
Initial Date of Registration : 2013-09-10
Latest Date of Registration : 2013-09-10
A Gadoteridol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadoteridol, including repackagers and relabelers. The FDA regulates Gadoteridol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadoteridol 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 Gadoteridol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadoteridol supplier is an individual or a company that provides Gadoteridol active pharmaceutical ingredient (API) or Gadoteridol finished formulations upon request. The Gadoteridol suppliers may include Gadoteridol API manufacturers, exporters, distributors and traders.
click here to find a list of Gadoteridol 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 Gadoteridol Drug Master File in Japan (Gadoteridol JDMF) empowers Gadoteridol 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 Gadoteridol JDMF during the approval evaluation for pharmaceutical products. At the time of Gadoteridol 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 Gadoteridol suppliers with JDMF on PharmaCompass.
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