01 1Merck Serono
01 1N,N-DICYCLOHEXYLCARBODIIMIDE, PRODUCT #11650
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3423
Submission : 1979-01-19
Status : Inactive
Type : II
A N,N-Dicyclohexylcarbodiimide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N,N-Dicyclohexylcarbodiimide, including repackagers and relabelers. The FDA regulates N,N-Dicyclohexylcarbodiimide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N,N-Dicyclohexylcarbodiimide 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 N,N-Dicyclohexylcarbodiimide supplier is an individual or a company that provides N,N-Dicyclohexylcarbodiimide active pharmaceutical ingredient (API) or N,N-Dicyclohexylcarbodiimide finished formulations upon request. The N,N-Dicyclohexylcarbodiimide suppliers may include N,N-Dicyclohexylcarbodiimide API manufacturers, exporters, distributors and traders.
click here to find a list of N,N-Dicyclohexylcarbodiimide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N,N-Dicyclohexylcarbodiimide DMF (Drug Master File) is a document detailing the whole manufacturing process of N,N-Dicyclohexylcarbodiimide active pharmaceutical ingredient (API) in detail. Different forms of N,N-Dicyclohexylcarbodiimide DMFs exist exist since differing nations have different regulations, such as N,N-Dicyclohexylcarbodiimide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N,N-Dicyclohexylcarbodiimide DMF submitted to regulatory agencies in the US is known as a USDMF. N,N-Dicyclohexylcarbodiimide USDMF includes data on N,N-Dicyclohexylcarbodiimide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N,N-Dicyclohexylcarbodiimide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N,N-Dicyclohexylcarbodiimide suppliers with USDMF on PharmaCompass.
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