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List of Korea Drug Master Files (KDMF) for Dotarem Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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GE Healthcare AS Korea Branch
2021-06-11
20210611-211-J-1026
GE Healthcare AS, Lindesn...
Norway
Lindesnesveien 208, Linde...
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Looking for 92943-93-6 / Gadoterate Meglumine API manufacturers, exporters & distributors?

Gadoterate Meglumine manufacturers, exporters & distributors 1

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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.

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.

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.

API | Excipient name

Gadoterate Meglumine

Synonyms

Magnescope, Meglumine gadoterate (jan), Gadoterate meglumine (usan), Gadoterate meglumine [usan], Meglumine gadoterate [jan], Magnescope (tn)

Cas Number

92943-93-6

Unique Ingredient Identifier (UNII)

L0ND3981AG

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
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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.
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