01 1Bayer AG
01 1FLUOCORTIN BUTYLESTER (RECOMMENDED GENERIC NAME IS FLUOCORTIN BUTYL)
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2862
Submission : 1977-02-10
Status : Inactive
Type : II
A Fluocortin Butyl Ester manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluocortin Butyl Ester, including repackagers and relabelers. The FDA regulates Fluocortin Butyl Ester manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluocortin Butyl Ester 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 Fluocortin Butyl Ester supplier is an individual or a company that provides Fluocortin Butyl Ester active pharmaceutical ingredient (API) or Fluocortin Butyl Ester finished formulations upon request. The Fluocortin Butyl Ester suppliers may include Fluocortin Butyl Ester API manufacturers, exporters, distributors and traders.
click here to find a list of Fluocortin Butyl Ester suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluocortin Butyl Ester DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluocortin Butyl Ester active pharmaceutical ingredient (API) in detail. Different forms of Fluocortin Butyl Ester DMFs exist exist since differing nations have different regulations, such as Fluocortin Butyl Ester USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluocortin Butyl Ester DMF submitted to regulatory agencies in the US is known as a USDMF. Fluocortin Butyl Ester USDMF includes data on Fluocortin Butyl Ester's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluocortin Butyl Ester USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluocortin Butyl Ester suppliers with USDMF on PharmaCompass.
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