01 1Avanti Polar Lipids
02 1NOF CORPORATION
01 11,2-DILAUROYL-SN-GLYCERO-3-PHOSPHOCHOLINE
02 1DIERUCOYL PHOSPHATIDYLCHOLINE (DEPC)
01 1Japan
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9680
Submission : 1992-05-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19022
Submission : 2005-12-09
Status : Active
Type : II
A Dilauroylphosphatidylcholine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dilauroylphosphatidylcholine, including repackagers and relabelers. The FDA regulates Dilauroylphosphatidylcholine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dilauroylphosphatidylcholine 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 Dilauroylphosphatidylcholine supplier is an individual or a company that provides Dilauroylphosphatidylcholine active pharmaceutical ingredient (API) or Dilauroylphosphatidylcholine finished formulations upon request. The Dilauroylphosphatidylcholine suppliers may include Dilauroylphosphatidylcholine API manufacturers, exporters, distributors and traders.
click here to find a list of Dilauroylphosphatidylcholine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dilauroylphosphatidylcholine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dilauroylphosphatidylcholine active pharmaceutical ingredient (API) in detail. Different forms of Dilauroylphosphatidylcholine DMFs exist exist since differing nations have different regulations, such as Dilauroylphosphatidylcholine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dilauroylphosphatidylcholine DMF submitted to regulatory agencies in the US is known as a USDMF. Dilauroylphosphatidylcholine USDMF includes data on Dilauroylphosphatidylcholine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dilauroylphosphatidylcholine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dilauroylphosphatidylcholine suppliers with USDMF on PharmaCompass.
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