01 1The University of Texas MD Anderson Cancer Center
01 1F 18 SODIUM FLUOROACETATE (18F-FACE) INJECTION
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26714
Submission : 2013-02-28
Status : Inactive
Type : II
A Fluoroacetic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluoroacetic Acid, including repackagers and relabelers. The FDA regulates Fluoroacetic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluoroacetic Acid 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 Fluoroacetic Acid supplier is an individual or a company that provides Fluoroacetic Acid active pharmaceutical ingredient (API) or Fluoroacetic Acid finished formulations upon request. The Fluoroacetic Acid suppliers may include Fluoroacetic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Fluoroacetic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluoroacetic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluoroacetic Acid active pharmaceutical ingredient (API) in detail. Different forms of Fluoroacetic Acid DMFs exist exist since differing nations have different regulations, such as Fluoroacetic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluoroacetic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Fluoroacetic Acid USDMF includes data on Fluoroacetic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluoroacetic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluoroacetic Acid suppliers with USDMF on PharmaCompass.
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