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 liquid
01 1United Kingdom
02 1Blank
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
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PharmaCompass offers a list of Gadoterate Meglumine 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 Gadoterate Meglumine manufacturer or Gadoterate Meglumine supplier for your needs.
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PharmaCompass also assists you with knowing the Gadoterate Meglumine API Price utilized in the formulation of products. Gadoterate Meglumine API Price is not always fixed or binding as the Gadoterate Meglumine Price is obtained through a variety of data sources. The Gadoterate Meglumine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gd-DOTA Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gd-DOTA Meglumine, including repackagers and relabelers. The FDA regulates Gd-DOTA Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gd-DOTA 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.
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A Gd-DOTA Meglumine supplier is an individual or a company that provides Gd-DOTA Meglumine active pharmaceutical ingredient (API) or Gd-DOTA Meglumine finished formulations upon request. The Gd-DOTA Meglumine suppliers may include Gd-DOTA Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Gd-DOTA Meglumine 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 Gd-DOTA Meglumine Drug Master File in Korea (Gd-DOTA Meglumine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gd-DOTA Meglumine. The MFDS reviews the Gd-DOTA Meglumine KDMF as part of the drug registration process and uses the information provided in the Gd-DOTA Meglumine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gd-DOTA 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 Gd-DOTA Meglumine API can apply through the Korea Drug Master File (KDMF).
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