01 1Trasis
01 1THE SYNTHESIS PATHWAY OF [18F]FDOPA
01 1Belgium
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34183
Submission : 2021-07-12
Status : Active
Type : II
A Fluorodopa F 18 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorodopa F 18, including repackagers and relabelers. The FDA regulates Fluorodopa F 18 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorodopa 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 Fluorodopa F 18 supplier is an individual or a company that provides Fluorodopa F 18 active pharmaceutical ingredient (API) or Fluorodopa F 18 finished formulations upon request. The Fluorodopa F 18 suppliers may include Fluorodopa F 18 API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorodopa F 18 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorodopa F 18 DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorodopa F 18 active pharmaceutical ingredient (API) in detail. Different forms of Fluorodopa F 18 DMFs exist exist since differing nations have different regulations, such as Fluorodopa F 18 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorodopa F 18 DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorodopa F 18 USDMF includes data on Fluorodopa F 18's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorodopa F 18 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorodopa F 18 suppliers with USDMF on PharmaCompass.
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