01 1Immunophotonics
02 1Servier
03 2Blank
01 1DEXFENFLURAMINE BASE
02 2DEXFENFLURAMINE HYDROCHLORIDE
03 1IP-001 DRUG SUBSTANCE
01 1France
02 1U.S.A
03 2Blank
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37937
Submission : 2023-02-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10106
Submission : 1993-02-26
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10873
Submission : 1994-04-14
Status : Inactive
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 : 11985
Submission : 1996-06-03
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Dexfenfluramine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexfenfluramine, including repackagers and relabelers. The FDA regulates Dexfenfluramine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexfenfluramine 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 Dexfenfluramine supplier is an individual or a company that provides Dexfenfluramine active pharmaceutical ingredient (API) or Dexfenfluramine finished formulations upon request. The Dexfenfluramine suppliers may include Dexfenfluramine API manufacturers, exporters, distributors and traders.
click here to find a list of Dexfenfluramine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexfenfluramine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexfenfluramine active pharmaceutical ingredient (API) in detail. Different forms of Dexfenfluramine DMFs exist exist since differing nations have different regulations, such as Dexfenfluramine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexfenfluramine DMF submitted to regulatory agencies in the US is known as a USDMF. Dexfenfluramine USDMF includes data on Dexfenfluramine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexfenfluramine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexfenfluramine suppliers with USDMF on PharmaCompass.
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