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01 1GE Healthcare AS, Lindesnes Site

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Gadoterate meglumine liquid

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

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Dotarem Manufacturers

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.

Dotarem Suppliers

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.

Dotarem KDMF

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.

Dotarem Manufacturers | Traders | Suppliers

Dotarem Manufacturers, Traders, Suppliers 1
46

We have 1 companies offering Dotarem

Get in contact with the supplier of your choice:

  1. GE Healthcare Inc
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.