01 1Avanti Polar Lipids
01 1N-HEXANOYL-D-ERYTHRO-SPHINGOSINE (C6 CERAMIDE)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16766
Submission : 2003-08-15
Status : Inactive
Type : II
A Sphingosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sphingosine, including repackagers and relabelers. The FDA regulates Sphingosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sphingosine 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 Sphingosine supplier is an individual or a company that provides Sphingosine active pharmaceutical ingredient (API) or Sphingosine finished formulations upon request. The Sphingosine suppliers may include Sphingosine API manufacturers, exporters, distributors and traders.
click here to find a list of Sphingosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sphingosine DMF (Drug Master File) is a document detailing the whole manufacturing process of Sphingosine active pharmaceutical ingredient (API) in detail. Different forms of Sphingosine DMFs exist exist since differing nations have different regulations, such as Sphingosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sphingosine DMF submitted to regulatory agencies in the US is known as a USDMF. Sphingosine USDMF includes data on Sphingosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sphingosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sphingosine suppliers with USDMF on PharmaCompass.
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