01 1Gilead Sciences
02 1NAGASE Europa GmbH
03 1Blank
01 12',3',5' TRI-O-ACETYLURIDINE
02 12',3',5'-TRI-O-ACETYLURIDINE
03 1TRIACETYLURIDINE
01 1Germany
02 1U.S.A
03 1Blank
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9517
Submission : 1992-01-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11241
Submission : 1994-12-13
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16448
Submission : 2003-02-28
Status : Inactive
Type : II
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A Triacetyluridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triacetyluridine, including repackagers and relabelers. The FDA regulates Triacetyluridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triacetyluridine 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 Triacetyluridine supplier is an individual or a company that provides Triacetyluridine active pharmaceutical ingredient (API) or Triacetyluridine finished formulations upon request. The Triacetyluridine suppliers may include Triacetyluridine API manufacturers, exporters, distributors and traders.
click here to find a list of Triacetyluridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triacetyluridine DMF (Drug Master File) is a document detailing the whole manufacturing process of Triacetyluridine active pharmaceutical ingredient (API) in detail. Different forms of Triacetyluridine DMFs exist exist since differing nations have different regulations, such as Triacetyluridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triacetyluridine DMF submitted to regulatory agencies in the US is known as a USDMF. Triacetyluridine USDMF includes data on Triacetyluridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triacetyluridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triacetyluridine suppliers with USDMF on PharmaCompass.
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