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