Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Bayer AG
03 1Sichuan Renan Pharmaceutical
01 1EOB-DTPA
02 2GADOXETATE DISODIUM
01 1China
02 1Germany
03 1India
01 2Active
02 1Inactive
01 1Complete
02 2Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-11-12
Pay. Date : 2025-09-17
DMF Number : 41810
Submission : 2025-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20414
Submission : 2007-05-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39660
Submission : 2024-04-01
Status : Inactive
Type : II
15
PharmaCompass offers a list of Gadolinium Ethoxybenzyl Dtpa 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 Gadolinium Ethoxybenzyl Dtpa manufacturer or Gadolinium Ethoxybenzyl Dtpa supplier for your needs.
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A Gd-EOB-DTPA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gd-EOB-DTPA, including repackagers and relabelers. The FDA regulates Gd-EOB-DTPA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gd-EOB-DTPA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Gd-EOB-DTPA supplier is an individual or a company that provides Gd-EOB-DTPA active pharmaceutical ingredient (API) or Gd-EOB-DTPA finished formulations upon request. The Gd-EOB-DTPA suppliers may include Gd-EOB-DTPA API manufacturers, exporters, distributors and traders.
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A Gd-EOB-DTPA DMF (Drug Master File) is a document detailing the whole manufacturing process of Gd-EOB-DTPA active pharmaceutical ingredient (API) in detail. Different forms of Gd-EOB-DTPA DMFs exist exist since differing nations have different regulations, such as Gd-EOB-DTPA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gd-EOB-DTPA DMF submitted to regulatory agencies in the US is known as a USDMF. Gd-EOB-DTPA USDMF includes data on Gd-EOB-DTPA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gd-EOB-DTPA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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