01 1Bayer AG
01 1IOTROL USING 5-NITROISOPHTHALIC ACID AS STARTING MATERIAL
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5103
Submission : 1983-08-23
Status : Inactive
Type : II
A Iotrolan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iotrolan, including repackagers and relabelers. The FDA regulates Iotrolan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iotrolan 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 Iotrolan supplier is an individual or a company that provides Iotrolan active pharmaceutical ingredient (API) or Iotrolan finished formulations upon request. The Iotrolan suppliers may include Iotrolan API manufacturers, exporters, distributors and traders.
click here to find a list of Iotrolan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iotrolan DMF (Drug Master File) is a document detailing the whole manufacturing process of Iotrolan active pharmaceutical ingredient (API) in detail. Different forms of Iotrolan DMFs exist exist since differing nations have different regulations, such as Iotrolan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iotrolan DMF submitted to regulatory agencies in the US is known as a USDMF. Iotrolan USDMF includes data on Iotrolan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iotrolan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iotrolan suppliers with USDMF on PharmaCompass.
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