01 1Vertellus
01 1ACETYLTRI-N-BUTYL CITRATE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7425
Submission : 1988-04-11
Status : Inactive
Type : II
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A ATBC plasticizer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ATBC plasticizer, including repackagers and relabelers. The FDA regulates ATBC plasticizer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ATBC plasticizer 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 ATBC plasticizer supplier is an individual or a company that provides ATBC plasticizer active pharmaceutical ingredient (API) or ATBC plasticizer finished formulations upon request. The ATBC plasticizer suppliers may include ATBC plasticizer API manufacturers, exporters, distributors and traders.
click here to find a list of ATBC plasticizer suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ATBC plasticizer DMF (Drug Master File) is a document detailing the whole manufacturing process of ATBC plasticizer active pharmaceutical ingredient (API) in detail. Different forms of ATBC plasticizer DMFs exist exist since differing nations have different regulations, such as ATBC plasticizer USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ATBC plasticizer DMF submitted to regulatory agencies in the US is known as a USDMF. ATBC plasticizer USDMF includes data on ATBC plasticizer's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ATBC plasticizer USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ATBC plasticizer suppliers with USDMF on PharmaCompass.
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