01 1GENERAL ELECTRIC
02 1HUAYI ISOTOPE CO
03 1Rotem Industries
04 3Blank
01 118F 2-FLUORO-2-DEOXYGLUCOSE
02 118F-FDG REAGENT KITS
03 1DILUENT FOR USE IN F-18 FLUDEOXYGLUCOSE MANUFACTURING
04 1F-18 FLUDEOXYGLUCOSE (MICHIGAN SYNTHESIS)
05 2FLUDEOXYGLUCOSE F-18 INJECTION
01 1China
02 1Israel
03 1U.S.A
04 3Blank
01 2Active
02 4Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13268
Submission : 1998-06-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30323
Submission : 2016-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30031
Submission : 2015-11-16
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9057
Submission : 1991-04-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9250
Submission : 1991-06-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9141
Submission : 1991-05-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Fluorodeoxyglucose F18 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorodeoxyglucose F18, including repackagers and relabelers. The FDA regulates Fluorodeoxyglucose F18 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorodeoxyglucose F18 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 Fluorodeoxyglucose F18 supplier is an individual or a company that provides Fluorodeoxyglucose F18 active pharmaceutical ingredient (API) or Fluorodeoxyglucose F18 finished formulations upon request. The Fluorodeoxyglucose F18 suppliers may include Fluorodeoxyglucose F18 API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorodeoxyglucose F18 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorodeoxyglucose F18 DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorodeoxyglucose F18 active pharmaceutical ingredient (API) in detail. Different forms of Fluorodeoxyglucose F18 DMFs exist exist since differing nations have different regulations, such as Fluorodeoxyglucose F18 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorodeoxyglucose F18 DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorodeoxyglucose F18 USDMF includes data on Fluorodeoxyglucose F18's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorodeoxyglucose F18 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorodeoxyglucose F18 suppliers with USDMF on PharmaCompass.
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