01 1Avanti Polar Lipids
01 1TETRAMYRISTOYL CARDIOLIPIN (14:0 CA)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12018
Submission : 1996-06-28
Status : Inactive
Type : II
A Tetramyristoylcardiolipin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetramyristoylcardiolipin, including repackagers and relabelers. The FDA regulates Tetramyristoylcardiolipin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetramyristoylcardiolipin 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 Tetramyristoylcardiolipin supplier is an individual or a company that provides Tetramyristoylcardiolipin active pharmaceutical ingredient (API) or Tetramyristoylcardiolipin finished formulations upon request. The Tetramyristoylcardiolipin suppliers may include Tetramyristoylcardiolipin API manufacturers, exporters, distributors and traders.
click here to find a list of Tetramyristoylcardiolipin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tetramyristoylcardiolipin DMF (Drug Master File) is a document detailing the whole manufacturing process of Tetramyristoylcardiolipin active pharmaceutical ingredient (API) in detail. Different forms of Tetramyristoylcardiolipin DMFs exist exist since differing nations have different regulations, such as Tetramyristoylcardiolipin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tetramyristoylcardiolipin DMF submitted to regulatory agencies in the US is known as a USDMF. Tetramyristoylcardiolipin USDMF includes data on Tetramyristoylcardiolipin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tetramyristoylcardiolipin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tetramyristoylcardiolipin suppliers with USDMF on PharmaCompass.
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