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