01 1Vertellus
01 1ACETYLTRI-N-HEXYL CITRATE (ATHC)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8888
Submission : 1990-12-13
Status : Active
Type : II
95
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A Acetyl Trihexyl Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetyl Trihexyl Citrate, including repackagers and relabelers. The FDA regulates Acetyl Trihexyl Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetyl Trihexyl 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 Trihexyl Citrate supplier is an individual or a company that provides Acetyl Trihexyl Citrate active pharmaceutical ingredient (API) or Acetyl Trihexyl Citrate finished formulations upon request. The Acetyl Trihexyl Citrate suppliers may include Acetyl Trihexyl Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Acetyl Trihexyl Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Acetyl Trihexyl Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetyl Trihexyl Citrate active pharmaceutical ingredient (API) in detail. Different forms of Acetyl Trihexyl Citrate DMFs exist exist since differing nations have different regulations, such as Acetyl Trihexyl Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetyl Trihexyl Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Acetyl Trihexyl Citrate USDMF includes data on Acetyl Trihexyl Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetyl Trihexyl Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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