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List of Drug Master Files (JDMF) for Gadodiamide Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 FORMOSA LABORATORIES, INC. (1)

02 GE Healthcare AS (1)

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01 Gadodiamide hydrate (2)

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01 Taiwan (1)

02 United Kingdom (1)

URL Supplier Web Content
220MF10205
36 Hoping Street, Louchu, Taoyuan 3...
2008-11-25
2008-09-29
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URL Supplier Web Content
217MF10960
Lindesnesveien 208, 4521 Lindesnes,...
2010-03-02
2005-11-14
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Looking for 131410-48-5 / Gadodiamide API manufacturers, exporters & distributors?

Gadodiamide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Gadodiamide

Synonyms

131410-48-5, Omniscan, 2-[bis[2-[carboxylatomethyl-[2-(methylamino)-2-oxoethyl]amino]ethyl]amino]acetate;gadolinium(3+), 122795-43-1, Omniscan (tn), Gadodiamide anhydrous

Cas Number

131410-48-5

Unique Ingredient Identifier (UNII)

84F6U3J2R6

About Gadodiamide

Gadodiamide is a paramagnetic gadolinium-based contrast agent (GBCA), with imaging activity upon magnetic resonance imaging (MRI). When placed in a magnetic field, gadodiamide generates a large local magnetic field, which can enhance the relaxation rate of nearby protons. This change in proton relaxation dynamics, iincreases the MRI signal intensity of tissues in which gadodiamide has accumulated; therefore, visualization of those tissues is enhanced.

Gadodiamide Manufacturers

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

Gadodiamide Suppliers

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

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

Gadodiamide JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Gadodiamide Drug Master File in Japan (Gadodiamide JDMF) empowers Gadodiamide API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Gadodiamide JDMF during the approval evaluation for pharmaceutical products. At the time of Gadodiamide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Gadodiamide suppliers with JDMF on PharmaCompass.

Gadodiamide Manufacturers | Traders | Suppliers

Gadodiamide Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Gadodiamide

Get in contact with the supplier of your choice:

  1. Formosa Laboratories
  2. 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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