01 1SIGMA TAU
01 1CHOLINE CHLORIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3013
Submission : 1977-07-29
Status : Inactive
Type : II
A Choline Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Choline Chloride, including repackagers and relabelers. The FDA regulates Choline Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Choline Chloride 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 Choline Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Choline Chloride supplier is an individual or a company that provides Choline Chloride active pharmaceutical ingredient (API) or Choline Chloride finished formulations upon request. The Choline Chloride suppliers may include Choline Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Choline Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Choline Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Choline Chloride active pharmaceutical ingredient (API) in detail. Different forms of Choline Chloride DMFs exist exist since differing nations have different regulations, such as Choline Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Choline Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Choline Chloride USDMF includes data on Choline Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Choline Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Choline Chloride suppliers with USDMF on PharmaCompass.
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