01 3NOF CORPORATION
01 1HIGH PURITY EGG YOLK PHOSPHATIDYLCHOLINE (HP-EPC)
02 1HSPC (PURIFIED HYDROGENATED SOY PHOSPHATIDYLCHOLINE)
03 1POPC (FN) (1-PALMITOYL-2-OLEOYL PHOSPHATIDYLCHOLINE)
01 3Japan
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16987
Submission : 2003-11-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22208
Submission : 2008-11-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20764
Submission : 2007-08-08
Status : Active
Type : II
A Phosphatidylcholines manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phosphatidylcholines, including repackagers and relabelers. The FDA regulates Phosphatidylcholines manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phosphatidylcholines API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Phosphatidylcholines manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phosphatidylcholines supplier is an individual or a company that provides Phosphatidylcholines active pharmaceutical ingredient (API) or Phosphatidylcholines finished formulations upon request. The Phosphatidylcholines suppliers may include Phosphatidylcholines API manufacturers, exporters, distributors and traders.
click here to find a list of Phosphatidylcholines suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phosphatidylcholines DMF (Drug Master File) is a document detailing the whole manufacturing process of Phosphatidylcholines active pharmaceutical ingredient (API) in detail. Different forms of Phosphatidylcholines DMFs exist exist since differing nations have different regulations, such as Phosphatidylcholines USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phosphatidylcholines DMF submitted to regulatory agencies in the US is known as a USDMF. Phosphatidylcholines USDMF includes data on Phosphatidylcholines's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phosphatidylcholines USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phosphatidylcholines suppliers with USDMF on PharmaCompass.
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