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01 1SODIUM IOTHALAMATE I-125 INJECTION
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8265
Submission : 1989-10-27
Status : Inactive
Type : II
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A Iothalamate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iothalamate Sodium, including repackagers and relabelers. The FDA regulates Iothalamate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iothalamate Sodium 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 Iothalamate Sodium supplier is an individual or a company that provides Iothalamate Sodium active pharmaceutical ingredient (API) or Iothalamate Sodium finished formulations upon request. The Iothalamate Sodium suppliers may include Iothalamate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Iothalamate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iothalamate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Iothalamate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Iothalamate Sodium DMFs exist exist since differing nations have different regulations, such as Iothalamate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iothalamate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Iothalamate Sodium USDMF includes data on Iothalamate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iothalamate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iothalamate Sodium suppliers with USDMF on PharmaCompass.
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