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