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List of Drug Master Files (DMF) of Gadobutrol Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Bayer AG (1)

03 Formosa Laboratories (1)

04 Jiangsu Hengrui Medicine (1)

05 MSN Laboratories (1)

06 ST Pharma (1)

07 Sichuan Renan Pharmaceutical (1)

08 Viwit Pharmaceuticals Limited (1)

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01 GADOBUTROL (3)

02 GADOBUTROL MONOHYDRATE (3)

03 GADOBUTROL MONOHYDRATE USP (1)

04 GADOBUTROL USP (1)

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01 China (3)

02 Germany (1)

03 India (2)

04 South Korea (1)

05 Taiwan (1)

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01 Active (8)

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01 Complete (4)

02 Blank (4)

URL Supplier Web Content
13061
Active
1998-07-07
N/A
II
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URL Supplier Web Content
36660
Active
2021-12-30
N/A
II
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URL Supplier Web Content
34832
Active
2020-05-28
Complete
2020-06-19
2020-04-29
II
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URL Supplier Web Content
36996
Active
2022-03-31
Complete
2023-09-25
2023-08-29
II
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URL Supplier Web Content
38579
Active
2023-08-18
N/A
II
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URL Supplier Web Content
35662
Active
2021-02-26
Complete
2021-03-30
2021-02-26
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URL Supplier Web Content
39094
Active
2023-11-24
N/A
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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 USDMF

A Gadobutrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Gadobutrol active pharmaceutical ingredient (API) in detail. Different forms of Gadobutrol DMFs exist exist since differing nations have different regulations, such as Gadobutrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Gadobutrol DMF submitted to regulatory agencies in the US is known as a USDMF. Gadobutrol USDMF includes data on Gadobutrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gadobutrol USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Gadobutrol suppliers with USDMF on PharmaCompass.

Gadobutrol Manufacturers | Traders | Suppliers

Gadobutrol Manufacturers, Traders, Suppliers 1
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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