01 1Daiichi Sankyo
01 1CEFMETAZOLE (FREE ACID)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9887
Submission : 1982-09-03
Status : Inactive
Type : II
48
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A CMZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CMZ, including repackagers and relabelers. The FDA regulates CMZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CMZ API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A CMZ supplier is an individual or a company that provides CMZ active pharmaceutical ingredient (API) or CMZ finished formulations upon request. The CMZ suppliers may include CMZ API manufacturers, exporters, distributors and traders.
click here to find a list of CMZ suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A CMZ DMF (Drug Master File) is a document detailing the whole manufacturing process of CMZ active pharmaceutical ingredient (API) in detail. Different forms of CMZ DMFs exist exist since differing nations have different regulations, such as CMZ USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CMZ DMF submitted to regulatory agencies in the US is known as a USDMF. CMZ USDMF includes data on CMZ's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CMZ USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CMZ suppliers with USDMF on PharmaCompass.
