01 1Avanti Polar Lipids
01 11,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOETHANOLAMINE-N-[METHOXY(POLYETHYLENE GLYCOL) 2000] (AMMONIUM SALT) (DSPE MPEG2000) (770120)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33335
Submission : 2018-11-21
Status : Active
Type : II
A PEG2000 DSPE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PEG2000 DSPE, including repackagers and relabelers. The FDA regulates PEG2000 DSPE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PEG2000 DSPE 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 PEG2000 DSPE supplier is an individual or a company that provides PEG2000 DSPE active pharmaceutical ingredient (API) or PEG2000 DSPE finished formulations upon request. The PEG2000 DSPE suppliers may include PEG2000 DSPE API manufacturers, exporters, distributors and traders.
click here to find a list of PEG2000 DSPE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PEG2000 DSPE DMF (Drug Master File) is a document detailing the whole manufacturing process of PEG2000 DSPE active pharmaceutical ingredient (API) in detail. Different forms of PEG2000 DSPE DMFs exist exist since differing nations have different regulations, such as PEG2000 DSPE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PEG2000 DSPE DMF submitted to regulatory agencies in the US is known as a USDMF. PEG2000 DSPE USDMF includes data on PEG2000 DSPE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PEG2000 DSPE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PEG2000 DSPE suppliers with USDMF on PharmaCompass.
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