01 1F.I.S. Fabbrica Italiana Sintetici
01 1CMT
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17059
Submission : 2003-12-19
Status : Inactive
Type : II
A 4-Des-Dimethylaminotetracycline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 4-Des-Dimethylaminotetracycline, including repackagers and relabelers. The FDA regulates 4-Des-Dimethylaminotetracycline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 4-Des-Dimethylaminotetracycline 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 4-Des-Dimethylaminotetracycline supplier is an individual or a company that provides 4-Des-Dimethylaminotetracycline active pharmaceutical ingredient (API) or 4-Des-Dimethylaminotetracycline finished formulations upon request. The 4-Des-Dimethylaminotetracycline suppliers may include 4-Des-Dimethylaminotetracycline API manufacturers, exporters, distributors and traders.
click here to find a list of 4-Des-Dimethylaminotetracycline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 4-Des-Dimethylaminotetracycline DMF (Drug Master File) is a document detailing the whole manufacturing process of 4-Des-Dimethylaminotetracycline active pharmaceutical ingredient (API) in detail. Different forms of 4-Des-Dimethylaminotetracycline DMFs exist exist since differing nations have different regulations, such as 4-Des-Dimethylaminotetracycline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 4-Des-Dimethylaminotetracycline DMF submitted to regulatory agencies in the US is known as a USDMF. 4-Des-Dimethylaminotetracycline USDMF includes data on 4-Des-Dimethylaminotetracycline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 4-Des-Dimethylaminotetracycline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 4-Des-Dimethylaminotetracycline suppliers with USDMF on PharmaCompass.
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