01 3Avanti Polar Lipids
02 1CordenPharma
03 1NOF CORPORATION
04 2Blank
01 41,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC)
02 11,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (DSPC) (730365)
03 1DISTEAROYLGLYCEROPHOCHLINE
04 1DSPC (DISTEAROYL PHOSPHATIDYLCHOLINE)
01 1Germany
02 1Japan
03 3U.S.A
04 2Blank
01 5Active
02 2Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25436
Submission : 2011-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21738
Submission : 2008-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5916
Submission : 1985-06-17
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14970
Submission : 2000-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19642
Submission : 2006-07-31
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40045
Submission : 2024-06-11
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40253
Submission : 2024-08-08
Status : Active
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A DSPC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSPC, including repackagers and relabelers. The FDA regulates DSPC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSPC 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 DSPC supplier is an individual or a company that provides DSPC active pharmaceutical ingredient (API) or DSPC finished formulations upon request. The DSPC suppliers may include DSPC API manufacturers, exporters, distributors and traders.
click here to find a list of DSPC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSPC DMF (Drug Master File) is a document detailing the whole manufacturing process of DSPC active pharmaceutical ingredient (API) in detail. Different forms of DSPC DMFs exist exist since differing nations have different regulations, such as DSPC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSPC DMF submitted to regulatory agencies in the US is known as a USDMF. DSPC USDMF includes data on DSPC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSPC USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DSPC suppliers with USDMF on PharmaCompass.
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