01 1Avanti Polar Lipids
01 1L-THREO-DIHYDROSPHINGOSINE (SAFINGOL)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16608
Submission : 2003-06-02
Status : Active
Type : II
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PharmaCompass offers a list of Safingol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Safingol manufacturer or Safingol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Safingol manufacturer or Safingol supplier.
A Safingol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safingol, including repackagers and relabelers. The FDA regulates Safingol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safingol 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 Safingol supplier is an individual or a company that provides Safingol active pharmaceutical ingredient (API) or Safingol finished formulations upon request. The Safingol suppliers may include Safingol API manufacturers, exporters, distributors and traders.
click here to find a list of Safingol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Safingol DMF (Drug Master File) is a document detailing the whole manufacturing process of Safingol active pharmaceutical ingredient (API) in detail. Different forms of Safingol DMFs exist exist since differing nations have different regulations, such as Safingol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Safingol DMF submitted to regulatory agencies in the US is known as a USDMF. Safingol USDMF includes data on Safingol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Safingol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Safingol suppliers with USDMF on PharmaCompass.
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