01 1ACS DOBFAR SPA
01 1CEFOXITIN ACID
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11823
Submission : 1996-01-23
Status : Active
Type : II
23
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A CFX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CFX, including repackagers and relabelers. The FDA regulates CFX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CFX 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 CFX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A CFX supplier is an individual or a company that provides CFX active pharmaceutical ingredient (API) or CFX finished formulations upon request. The CFX suppliers may include CFX API manufacturers, exporters, distributors and traders.
click here to find a list of CFX suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A CFX DMF (Drug Master File) is a document detailing the whole manufacturing process of CFX active pharmaceutical ingredient (API) in detail. Different forms of CFX DMFs exist exist since differing nations have different regulations, such as CFX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CFX DMF submitted to regulatory agencies in the US is known as a USDMF. CFX USDMF includes data on CFX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CFX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CFX suppliers with USDMF on PharmaCompass.
