01 1KUREHA CORP
01 1KREMEZIN DRUG SUBSTANCE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16077
Submission : 2002-07-31
Status : Active
Type : II
A Carbon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbon, including repackagers and relabelers. The FDA regulates Carbon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbon 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 Carbon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbon supplier is an individual or a company that provides Carbon active pharmaceutical ingredient (API) or Carbon finished formulations upon request. The Carbon suppliers may include Carbon API manufacturers, exporters, distributors and traders.
click here to find a list of Carbon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbon DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbon active pharmaceutical ingredient (API) in detail. Different forms of Carbon DMFs exist exist since differing nations have different regulations, such as Carbon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbon DMF submitted to regulatory agencies in the US is known as a USDMF. Carbon USDMF includes data on Carbon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbon suppliers with USDMF on PharmaCompass.
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