01 1HOUSTON CYCLOTRON PARTNERS LP
02 2Blank
01 13'-DEOXY-3' -[18F] FLUOROTHYMIDINE ([18F]FLT) INJECTION
02 1FLUOROTHYMIDINE F-18
03 1[18] FLT, 3'-DEOXY-3'-[18F] FLUOROTHYMIDINE
01 1U.S.A
02 2Blank
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27573
Submission : 2013-12-06
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35564
Submission : 2021-02-05
Status : Active
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 : 28697
Submission : 2014-09-22
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Fluorothymidine F-18 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorothymidine F-18, including repackagers and relabelers. The FDA regulates Fluorothymidine F-18 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorothymidine 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 Fluorothymidine F-18 supplier is an individual or a company that provides Fluorothymidine F-18 active pharmaceutical ingredient (API) or Fluorothymidine F-18 finished formulations upon request. The Fluorothymidine F-18 suppliers may include Fluorothymidine F-18 API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorothymidine F-18 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorothymidine F-18 DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorothymidine F-18 active pharmaceutical ingredient (API) in detail. Different forms of Fluorothymidine F-18 DMFs exist exist since differing nations have different regulations, such as Fluorothymidine F-18 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorothymidine F-18 DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorothymidine F-18 USDMF includes data on Fluorothymidine F-18's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorothymidine F-18 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorothymidine F-18 suppliers with USDMF on PharmaCompass.
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