01 1Guerbet
01 1Gerbe Korea Co., Ltd.
01 1Gadopicleol
01 1France
Registrant Name : Gerbe Korea Co., Ltd.
Registration Date : 2026-01-12
Registration Number : Su405-1-ND
Manufacturer Name : Guerbet
Manufacturer Address : rue Denis PapinZI Kerpont, LANESTER, 56600, France
95
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A ELUCIREM manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ELUCIREM, including repackagers and relabelers. The FDA regulates ELUCIREM manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ELUCIREM 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 ELUCIREM manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ELUCIREM supplier is an individual or a company that provides ELUCIREM active pharmaceutical ingredient (API) or ELUCIREM finished formulations upon request. The ELUCIREM suppliers may include ELUCIREM API manufacturers, exporters, distributors and traders.
click here to find a list of ELUCIREM suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 ELUCIREM Drug Master File in Korea (ELUCIREM KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ELUCIREM. The MFDS reviews the ELUCIREM KDMF as part of the drug registration process and uses the information provided in the ELUCIREM KDMF to evaluate the safety and efficacy of the drug.
After submitting a ELUCIREM 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 ELUCIREM API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ELUCIREM suppliers with KDMF on PharmaCompass.
