01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
02 1IBA molecular
03 1Siemens Molecular Imaging
04 1TRIAD ISOTOPES INC
05 1Blank
01 1FLUORINE-18 SODIUM FLUORIDE
02 1SODIUM FLUORIDE F18 INJECTION
03 1SODIUM RADIOFLUORIDE
04 1SODIUM [18F] FLUORIDE ([18F]NAF) FOR INJECTION
05 1[F-18] FDPN
01 1Belgium
02 1Germany
03 2U.S.A
04 1Blank
01 5Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24168
Submission : 2010-09-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22029
Submission : 2008-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21582
Submission : 2008-04-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24083
Submission : 2010-08-18
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1442
Submission : 1969-10-28
Status : Inactive
Type : II
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A Sodium Fluoride 18F manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Fluoride 18F, including repackagers and relabelers. The FDA regulates Sodium Fluoride 18F manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Fluoride 18F 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 Sodium Fluoride 18F supplier is an individual or a company that provides Sodium Fluoride 18F active pharmaceutical ingredient (API) or Sodium Fluoride 18F finished formulations upon request. The Sodium Fluoride 18F suppliers may include Sodium Fluoride 18F API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Fluoride 18F suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Fluoride 18F DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Fluoride 18F active pharmaceutical ingredient (API) in detail. Different forms of Sodium Fluoride 18F DMFs exist exist since differing nations have different regulations, such as Sodium Fluoride 18F USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Fluoride 18F DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Fluoride 18F USDMF includes data on Sodium Fluoride 18F's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Fluoride 18F USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Fluoride 18F suppliers with USDMF on PharmaCompass.
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