01 1CordenPharma
02 1NOF CORPORATION
01 11,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, SODIUM SALT (DSPG, NA)
02 1DISTEAROYL PHOSPHATIDYL GLYCEROL SODIUM SALT (DSPG-NA)
01 1Germany
02 1Japan
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12233
Submission : 1996-11-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20474
Submission : 2007-04-25
Status : Active
Type : II
A DSPG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSPG, including repackagers and relabelers. The FDA regulates DSPG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSPG 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 DSPG supplier is an individual or a company that provides DSPG active pharmaceutical ingredient (API) or DSPG finished formulations upon request. The DSPG suppliers may include DSPG API manufacturers, exporters, distributors and traders.
click here to find a list of DSPG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSPG DMF (Drug Master File) is a document detailing the whole manufacturing process of DSPG active pharmaceutical ingredient (API) in detail. Different forms of DSPG DMFs exist exist since differing nations have different regulations, such as DSPG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSPG DMF submitted to regulatory agencies in the US is known as a USDMF. DSPG USDMF includes data on DSPG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSPG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DSPG suppliers with USDMF on PharmaCompass.
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