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