01 1City of Hope
02 1IBA MOLECULAR NA
01 1(F-18) FET INJECTION
02 1(F-18)FLT
01 2U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35283
Submission : 2020-11-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20822
Submission : 2007-08-29
Status : Inactive
Type : II
A Fluoride Ion F-18 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluoride Ion F-18, including repackagers and relabelers. The FDA regulates Fluoride Ion F-18 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluoride Ion F-18 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 Fluoride Ion F-18 supplier is an individual or a company that provides Fluoride Ion F-18 active pharmaceutical ingredient (API) or Fluoride Ion F-18 finished formulations upon request. The Fluoride Ion F-18 suppliers may include Fluoride Ion F-18 API manufacturers, exporters, distributors and traders.
click here to find a list of Fluoride Ion F-18 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluoride Ion F-18 DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluoride Ion F-18 active pharmaceutical ingredient (API) in detail. Different forms of Fluoride Ion F-18 DMFs exist exist since differing nations have different regulations, such as Fluoride Ion F-18 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluoride Ion F-18 DMF submitted to regulatory agencies in the US is known as a USDMF. Fluoride Ion F-18 USDMF includes data on Fluoride Ion F-18's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluoride Ion F-18 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluoride Ion F-18 suppliers with USDMF on PharmaCompass.
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