01 1Recordati
01 1FENTICONAZOLE NITRATE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7864
Submission : 1989-01-13
Status : Inactive
Type : II
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A Fenticonazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenticonazole, including repackagers and relabelers. The FDA regulates Fenticonazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenticonazole 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 Fenticonazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Fenticonazole supplier is an individual or a company that provides Fenticonazole active pharmaceutical ingredient (API) or Fenticonazole finished formulations upon request. The Fenticonazole suppliers may include Fenticonazole API manufacturers, exporters, distributors and traders.
click here to find a list of Fenticonazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fenticonazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenticonazole active pharmaceutical ingredient (API) in detail. Different forms of Fenticonazole DMFs exist exist since differing nations have different regulations, such as Fenticonazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenticonazole DMF submitted to regulatory agencies in the US is known as a USDMF. Fenticonazole USDMF includes data on Fenticonazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenticonazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
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