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
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PharmaCompass offers a list of Gadobutrol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gadobutrol manufacturer or Gadobutrol supplier for your needs.
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PharmaCompass also assists you with knowing the Gadobutrol API Price utilized in the formulation of products. Gadobutrol API Price is not always fixed or binding as the Gadobutrol Price is obtained through a variety of data sources. The Gadobutrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A gadolinium-DO3A-butriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gadolinium-DO3A-butriol, including repackagers and relabelers. The FDA regulates gadolinium-DO3A-butriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gadolinium-DO3A-butriol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A gadolinium-DO3A-butriol supplier is an individual or a company that provides gadolinium-DO3A-butriol active pharmaceutical ingredient (API) or gadolinium-DO3A-butriol finished formulations upon request. The gadolinium-DO3A-butriol suppliers may include gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol Drug Master File in Japan (gadolinium-DO3A-butriol JDMF) empowers gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol JDMF during the approval evaluation for pharmaceutical products. At the time of gadolinium-DO3A-butriol 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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