01 1Bayer AG
02 1Sichuan Renan Pharmaceutical
01 1EOB-DTPA
02 1GADOXETATE DISODIUM
01 1China
02 1Germany
01 2Active
01 2Blank
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 : Active
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 primovist manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of primovist, including repackagers and relabelers. The FDA regulates primovist manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. primovist 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 primovist supplier is an individual or a company that provides primovist active pharmaceutical ingredient (API) or primovist finished formulations upon request. The primovist suppliers may include primovist API manufacturers, exporters, distributors and traders.
click here to find a list of primovist suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A primovist DMF (Drug Master File) is a document detailing the whole manufacturing process of primovist active pharmaceutical ingredient (API) in detail. Different forms of primovist DMFs exist exist since differing nations have different regulations, such as primovist USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A primovist DMF submitted to regulatory agencies in the US is known as a USDMF. primovist USDMF includes data on primovist's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The primovist USDMF is kept confidential to protect the manufacturer’s intellectual property.
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