01 1Anhui Poly Pharm Co., Ltd
02 1GE Healthcare AS, Lindesnes Site
01 1GE Healthcare AS Korea Branch
02 1Pharmapia Co., Ltd.
01 1Gadoterate meglumine
02 1Gadoterate meglumine solution
01 1China
02 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
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-04-30
Registration Number : 20250430-210-J-1890
Manufacturer Name : Anhui Poly Pharm Co., Ltd
Manufacturer Address : No.58 Xiahong Road,High-tech Industrial Development Zone,Anqin City,Anhui Province
86
PharmaCompass offers a list of Gadoterate Meglumine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Gadoterate Meglumine manufacturer or Gadoterate Meglumine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadoterate Meglumine manufacturer or Gadoterate Meglumine supplier.
A Gadoterate Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadoterate Meglumine, including repackagers and relabelers. The FDA regulates Gadoterate Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadoterate Meglumine 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 Gadoterate Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Gadoterate Meglumine supplier is an individual or a company that provides Gadoterate Meglumine active pharmaceutical ingredient (API) or Gadoterate Meglumine finished formulations upon request. The Gadoterate Meglumine suppliers may include Gadoterate Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Gadoterate Meglumine 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 Gadoterate Meglumine Drug Master File in Korea (Gadoterate Meglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gadoterate Meglumine. The MFDS reviews the Gadoterate Meglumine KDMF as part of the drug registration process and uses the information provided in the Gadoterate Meglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gadoterate Meglumine 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 Gadoterate Meglumine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gadoterate Meglumine suppliers with KDMF on PharmaCompass.
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