01 2Chemi SpA
02 1CordenPharma
01 11-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT
02 11-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL AMMONIUM SALT 95% POSITIONAL PURITY
03 11-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL SODIUM SALT (POPG NA)
01 1Germany
02 2Italy
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14976
Submission : 2000-07-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14094
Submission : 1999-04-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14429
Submission : 1999-09-28
Status : Active
Type : II
A POPG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of POPG, including repackagers and relabelers. The FDA regulates POPG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. POPG 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 POPG supplier is an individual or a company that provides POPG active pharmaceutical ingredient (API) or POPG finished formulations upon request. The POPG suppliers may include POPG API manufacturers, exporters, distributors and traders.
click here to find a list of POPG suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A POPG DMF (Drug Master File) is a document detailing the whole manufacturing process of POPG active pharmaceutical ingredient (API) in detail. Different forms of POPG DMFs exist exist since differing nations have different regulations, such as POPG USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A POPG DMF submitted to regulatory agencies in the US is known as a USDMF. POPG USDMF includes data on POPG's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The POPG USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of POPG suppliers with USDMF on PharmaCompass.
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