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List of Certificates of Suitability (CEPs) for Gadobutrol Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 BIOPHORE INDIA PHARMACEUTICALS PVT. LTD. Hyderabad IN (1)

02 BAYER AG Leverkusen DE (1)

03 ST PHARM CO., LTD. Ansan-Si KR (1)

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01 Gadobutrol monohydrate (3)

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01 Germany (1)

02 India (1)

03 South Korea (1)

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01 Valid (3)

URL Supplier Web Content
CEP 2017-275 - Rev 02
Valid
Chemical
2023-12-06
2735
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URL Supplier Web Content
R0-CEP 2020-015 - Rev 01
Valid
Chemical
2022-11-28
2735
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PHARMACOMPASS
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Looking for / Gadobutrol API manufacturers, exporters & distributors?

Gadobutrol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gadobutrol 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 Gadobutrol manufacturer or Gadobutrol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadobutrol manufacturer or Gadobutrol supplier.

PharmaCompass also assists you with knowing the Gadobutrol API Price utilized in the formulation of products. Gadobutrol API Price is not always fixed or binding as the Gadobutrol Price is obtained through a variety of data sources. The Gadobutrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gadobutrol

Gadobutrol Manufacturers

A Gadobutrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadobutrol, including repackagers and relabelers. The FDA regulates Gadobutrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadobutrol 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 Gadobutrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Gadobutrol Suppliers

A Gadobutrol supplier is an individual or a company that provides Gadobutrol active pharmaceutical ingredient (API) or Gadobutrol finished formulations upon request. The Gadobutrol suppliers may include Gadobutrol API manufacturers, exporters, distributors and traders.

click here to find a list of Gadobutrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Gadobutrol CEP

A Gadobutrol CEP of the European Pharmacopoeia monograph is often referred to as a Gadobutrol Certificate of Suitability (COS). The purpose of a Gadobutrol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gadobutrol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gadobutrol to their clients by showing that a Gadobutrol CEP has been issued for it. The manufacturer submits a Gadobutrol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gadobutrol CEP holder for the record. Additionally, the data presented in the Gadobutrol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gadobutrol DMF.

A Gadobutrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gadobutrol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Gadobutrol suppliers with CEP (COS) on PharmaCompass.

Gadobutrol Manufacturers | Traders | Suppliers

Gadobutrol Manufacturers, Traders, Suppliers 1
79

We have 3 companies offering Gadobutrol

Get in contact with the supplier of your choice:

  1. Biophore India Pharmaceuticals Pvt Ltd
  2. Bayer AG
  3. ST Pharma
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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