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01 1GOLD 198 COLLOID (RADIOISOTOPE) (FORMERLY HELD BY UNION CARBIDE CORP)
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1641
Submission : 1971-03-04
Status : Inactive
Type : II
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A Gold-198 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gold-198, including repackagers and relabelers. The FDA regulates Gold-198 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gold-198 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Gold-198 supplier is an individual or a company that provides Gold-198 active pharmaceutical ingredient (API) or Gold-198 finished formulations upon request. The Gold-198 suppliers may include Gold-198 API manufacturers, exporters, distributors and traders.
click here to find a list of Gold-198 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gold-198 DMF (Drug Master File) is a document detailing the whole manufacturing process of Gold-198 active pharmaceutical ingredient (API) in detail. Different forms of Gold-198 DMFs exist exist since differing nations have different regulations, such as Gold-198 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gold-198 DMF submitted to regulatory agencies in the US is known as a USDMF. Gold-198 USDMF includes data on Gold-198's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gold-198 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gold-198 suppliers with USDMF on PharmaCompass.
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