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 Acetyl Tributyl Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetyl Tributyl Citrate, including repackagers and relabelers. The FDA regulates Acetyl Tributyl Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetyl Tributyl Citrate 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 Acetyl Tributyl Citrate supplier is an individual or a company that provides Acetyl Tributyl Citrate active pharmaceutical ingredient (API) or Acetyl Tributyl Citrate finished formulations upon request. The Acetyl Tributyl Citrate suppliers may include Acetyl Tributyl Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Acetyl Tributyl Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Acetyl Tributyl Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetyl Tributyl Citrate active pharmaceutical ingredient (API) in detail. Different forms of Acetyl Tributyl Citrate DMFs exist exist since differing nations have different regulations, such as Acetyl Tributyl Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetyl Tributyl Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Acetyl Tributyl Citrate USDMF includes data on Acetyl Tributyl Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetyl Tributyl Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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