01 1Urquima S.A. Grupo Uriach
01 1FLUTRIMAZOLE
01 1Spain
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12806
Submission : 1997-12-24
Status : Inactive
Type : II
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A Micetal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Micetal, including repackagers and relabelers. The FDA regulates Micetal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Micetal 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 Micetal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Micetal supplier is an individual or a company that provides Micetal active pharmaceutical ingredient (API) or Micetal finished formulations upon request. The Micetal suppliers may include Micetal API manufacturers, exporters, distributors and traders.
click here to find a list of Micetal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Micetal DMF (Drug Master File) is a document detailing the whole manufacturing process of Micetal active pharmaceutical ingredient (API) in detail. Different forms of Micetal DMFs exist exist since differing nations have different regulations, such as Micetal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Micetal DMF submitted to regulatory agencies in the US is known as a USDMF. Micetal USDMF includes data on Micetal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Micetal USDMF is kept confidential to protect the manufacturer’s intellectual property.
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