01 1NOF CORPORATION
01 1DIPALMITOYL PHOSPHATIDYLGLYCEROL, SODIUM SALT (DPPG-NA)
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22318
Submission : 2008-12-17
Status : Active
Type : II
A 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate, including repackagers and relabelers. The FDA regulates 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate 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 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate supplier is an individual or a company that provides 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate active pharmaceutical ingredient (API) or 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate finished formulations upon request. The 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate suppliers may include 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate active pharmaceutical ingredient (API) in detail. Different forms of 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate DMFs exist exist since differing nations have different regulations, such as 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate USDMF includes data on 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1,2-Dipalmitoyl-Phosphatidylglycerol-Phosphate suppliers with USDMF on PharmaCompass.
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