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