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
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A Hepacholine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hepacholine, including repackagers and relabelers. The FDA regulates Hepacholine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hepacholine 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 Hepacholine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hepacholine supplier is an individual or a company that provides Hepacholine active pharmaceutical ingredient (API) or Hepacholine finished formulations upon request. The Hepacholine suppliers may include Hepacholine API manufacturers, exporters, distributors and traders.
click here to find a list of Hepacholine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Hepacholine DMF (Drug Master File) is a document detailing the whole manufacturing process of Hepacholine active pharmaceutical ingredient (API) in detail. Different forms of Hepacholine DMFs exist exist since differing nations have different regulations, such as Hepacholine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hepacholine DMF submitted to regulatory agencies in the US is known as a USDMF. Hepacholine USDMF includes data on Hepacholine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hepacholine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hepacholine suppliers with USDMF on PharmaCompass.
