01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
02 2Cardinal Health
03 1Yale Cancer Center
01 2FLUOROMISONIDAZOLE F 18 INJECTION
02 1FLUOROMISONIDAZOLE F18 INJECTION([18F]FMISO)
03 1[18F] FMISO
01 4U.S.A
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27297
Submission : 2013-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23002
Submission : 2009-06-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21691
Submission : 2008-06-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29993
Submission : 2015-11-05
Status : Active
Type : II
A Fluoromisonidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluoromisonidazole, including repackagers and relabelers. The FDA regulates Fluoromisonidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluoromisonidazole 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 Fluoromisonidazole supplier is an individual or a company that provides Fluoromisonidazole active pharmaceutical ingredient (API) or Fluoromisonidazole finished formulations upon request. The Fluoromisonidazole suppliers may include Fluoromisonidazole API manufacturers, exporters, distributors and traders.
click here to find a list of Fluoromisonidazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluoromisonidazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluoromisonidazole active pharmaceutical ingredient (API) in detail. Different forms of Fluoromisonidazole DMFs exist exist since differing nations have different regulations, such as Fluoromisonidazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluoromisonidazole DMF submitted to regulatory agencies in the US is known as a USDMF. Fluoromisonidazole USDMF includes data on Fluoromisonidazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluoromisonidazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluoromisonidazole suppliers with USDMF on PharmaCompass.
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