01 1Borregaard
02 1GUERBET
01 1IOXILAN BULK DRUG SUBSTANCE
02 1IOXITOL
01 1France
02 1Norway
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11893
Submission : 1996-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11270
Submission : 1994-12-27
Status : Inactive
Type : II
A Ioxilan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ioxilan, including repackagers and relabelers. The FDA regulates Ioxilan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ioxilan 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 Ioxilan supplier is an individual or a company that provides Ioxilan active pharmaceutical ingredient (API) or Ioxilan finished formulations upon request. The Ioxilan suppliers may include Ioxilan API manufacturers, exporters, distributors and traders.
click here to find a list of Ioxilan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ioxilan DMF (Drug Master File) is a document detailing the whole manufacturing process of Ioxilan active pharmaceutical ingredient (API) in detail. Different forms of Ioxilan DMFs exist exist since differing nations have different regulations, such as Ioxilan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ioxilan DMF submitted to regulatory agencies in the US is known as a USDMF. Ioxilan USDMF includes data on Ioxilan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ioxilan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ioxilan suppliers with USDMF on PharmaCompass.
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