01 1NOF CORPORATION
01 1DOPS-NA (DIOLEOYL PHOSPHATIDYLSERINE, SODIUM SALT)
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17320
Submission : 2004-05-07
Status : Active
Type : II
A Dioleoyl Phosphatidylserine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dioleoyl Phosphatidylserine, including repackagers and relabelers. The FDA regulates Dioleoyl Phosphatidylserine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dioleoyl Phosphatidylserine 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 Dioleoyl Phosphatidylserine supplier is an individual or a company that provides Dioleoyl Phosphatidylserine active pharmaceutical ingredient (API) or Dioleoyl Phosphatidylserine finished formulations upon request. The Dioleoyl Phosphatidylserine suppliers may include Dioleoyl Phosphatidylserine API manufacturers, exporters, distributors and traders.
click here to find a list of Dioleoyl Phosphatidylserine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dioleoyl Phosphatidylserine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dioleoyl Phosphatidylserine active pharmaceutical ingredient (API) in detail. Different forms of Dioleoyl Phosphatidylserine DMFs exist exist since differing nations have different regulations, such as Dioleoyl Phosphatidylserine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dioleoyl Phosphatidylserine DMF submitted to regulatory agencies in the US is known as a USDMF. Dioleoyl Phosphatidylserine USDMF includes data on Dioleoyl Phosphatidylserine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dioleoyl Phosphatidylserine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dioleoyl Phosphatidylserine suppliers with USDMF on PharmaCompass.
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