01 1DongKook Life Science Co. , Ltd.
01 1Gadobutrol
01 1South Korea
Registration Number : 305MF10082
Registrant's Address : 7, Teheran-ro 108-gil, Gangnam-gu, Seoul, Korea
Initial Date of Registration : 2023-07-19
Latest Date of Registration : 2023-07-19
A Gadobutrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadobutrol, including repackagers and relabelers. The FDA regulates Gadobutrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadobutrol 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 Gadobutrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gadobutrol supplier is an individual or a company that provides Gadobutrol active pharmaceutical ingredient (API) or Gadobutrol finished formulations upon request. The Gadobutrol suppliers may include Gadobutrol API manufacturers, exporters, distributors and traders.
click here to find a list of Gadobutrol 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 Gadobutrol Drug Master File in Japan (Gadobutrol JDMF) empowers Gadobutrol 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 Gadobutrol JDMF during the approval evaluation for pharmaceutical products. At the time of Gadobutrol 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 Gadobutrol suppliers with JDMF on PharmaCompass.
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