01 1SIGMA TAU
01 1COUMARIN
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5652
Submission : 1985-01-04
Status : Inactive
Type : II
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A CUMARINA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CUMARINA, including repackagers and relabelers. The FDA regulates CUMARINA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CUMARINA 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 CUMARINA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A CUMARINA supplier is an individual or a company that provides CUMARINA active pharmaceutical ingredient (API) or CUMARINA finished formulations upon request. The CUMARINA suppliers may include CUMARINA API manufacturers, exporters, distributors and traders.
click here to find a list of CUMARINA suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A CUMARINA DMF (Drug Master File) is a document detailing the whole manufacturing process of CUMARINA active pharmaceutical ingredient (API) in detail. Different forms of CUMARINA DMFs exist exist since differing nations have different regulations, such as CUMARINA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CUMARINA DMF submitted to regulatory agencies in the US is known as a USDMF. CUMARINA USDMF includes data on CUMARINA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CUMARINA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CUMARINA suppliers with USDMF on PharmaCompass.
