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