01 1Kyowa Hakko Bio
02 1SEQUENT SCIENTIFIC LTD
01 1CITICOLINE MONOSODIUM SALT
02 1CITICOLINE SODIUM
01 1India
02 1Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12724
Submission : 1997-10-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27708
Submission : 2013-11-11
Status : Inactive
Type : II
A Citicoline Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citicoline Sodium, including repackagers and relabelers. The FDA regulates Citicoline Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citicoline Sodium 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 Citicoline Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Citicoline Sodium supplier is an individual or a company that provides Citicoline Sodium active pharmaceutical ingredient (API) or Citicoline Sodium finished formulations upon request. The Citicoline Sodium suppliers may include Citicoline Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Citicoline Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Citicoline Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Citicoline Sodium active pharmaceutical ingredient (API) in detail. Different forms of Citicoline Sodium DMFs exist exist since differing nations have different regulations, such as Citicoline Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Citicoline Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Citicoline Sodium USDMF includes data on Citicoline Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Citicoline Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Citicoline Sodium suppliers with USDMF on PharmaCompass.
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