01 1Merck Serono
02 1Blank
01 1SODIUM DIETHYLDITHIOCARBAMATE
02 1SODIUM DIETHYLDITHIOCARBAMATE TRIHYDRATE-EXTRA PURE
01 1Germany
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6944
Submission : 1987-04-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9434
Submission : 1991-11-25
Status : Inactive
Type : II
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A Ditiocarb manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ditiocarb, including repackagers and relabelers. The FDA regulates Ditiocarb manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ditiocarb 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 Ditiocarb supplier is an individual or a company that provides Ditiocarb active pharmaceutical ingredient (API) or Ditiocarb finished formulations upon request. The Ditiocarb suppliers may include Ditiocarb API manufacturers, exporters, distributors and traders.
click here to find a list of Ditiocarb suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ditiocarb DMF (Drug Master File) is a document detailing the whole manufacturing process of Ditiocarb active pharmaceutical ingredient (API) in detail. Different forms of Ditiocarb DMFs exist exist since differing nations have different regulations, such as Ditiocarb USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ditiocarb DMF submitted to regulatory agencies in the US is known as a USDMF. Ditiocarb USDMF includes data on Ditiocarb's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ditiocarb USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ditiocarb suppliers with USDMF on PharmaCompass.
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