01 1GE Healthcare AS, Lindesnes Site
01 1GE Healthcare AS Korea Branch
01 1Gadoterate meglumine liquid
01 1United Kingdom
Registrant Name : GE Healthcare AS Korea Branch
Registration Date : 2021-06-11
Registration Number : 20210611-211-J-1026
Manufacturer Name : GE Healthcare AS, Lindesnes ...
Manufacturer Address : Lindesnesveien 208, Lindesnes, NO-4521, Norway
A Dotarem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dotarem, including repackagers and relabelers. The FDA regulates Dotarem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dotarem 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 Dotarem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dotarem supplier is an individual or a company that provides Dotarem active pharmaceutical ingredient (API) or Dotarem finished formulations upon request. The Dotarem suppliers may include Dotarem API manufacturers, exporters, distributors and traders.
click here to find a list of Dotarem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dotarem Drug Master File in Korea (Dotarem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dotarem. The MFDS reviews the Dotarem KDMF as part of the drug registration process and uses the information provided in the Dotarem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dotarem KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dotarem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dotarem suppliers with KDMF on PharmaCompass.
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