01 1Jiangsu Hengrui Medicine
02 2Mallinckrodt Pharmaceuticals
01 1IOVERSOL
02 1IOVERSOL USP, NON-STERILE, BULK DRUG SUBSTANCE
03 1IOVERSOL, DRUG SUBSTANCE FOR OPTIRAY
01 1China
02 2Ireland
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34108
Submission : 2019-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12259
Submission : 1996-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6972
Submission : 1987-05-13
Status : Active
Type : II
A Ioversol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ioversol, including repackagers and relabelers. The FDA regulates Ioversol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ioversol 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 Ioversol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ioversol supplier is an individual or a company that provides Ioversol active pharmaceutical ingredient (API) or Ioversol finished formulations upon request. The Ioversol suppliers may include Ioversol API manufacturers, exporters, distributors and traders.
click here to find a list of Ioversol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ioversol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ioversol active pharmaceutical ingredient (API) in detail. Different forms of Ioversol DMFs exist exist since differing nations have different regulations, such as Ioversol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ioversol DMF submitted to regulatory agencies in the US is known as a USDMF. Ioversol USDMF includes data on Ioversol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ioversol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ioversol suppliers with USDMF on PharmaCompass.
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