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01 1AstraZeneca
02 1Halocarbon Products
03 1Blank
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01 3HALOTHANE
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01 1U.S.A
02 1United Kingdom
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01 3Inactive
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01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10295
Submission : 1993-06-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11215
Submission : 1994-11-30
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2348
Submission : 1974-11-01
Status : Inactive
Type : II
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A Fluothane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluothane, including repackagers and relabelers. The FDA regulates Fluothane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluothane 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 Fluothane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluothane supplier is an individual or a company that provides Fluothane active pharmaceutical ingredient (API) or Fluothane finished formulations upon request. The Fluothane suppliers may include Fluothane API manufacturers, exporters, distributors and traders.
click here to find a list of Fluothane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluothane DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluothane active pharmaceutical ingredient (API) in detail. Different forms of Fluothane DMFs exist exist since differing nations have different regulations, such as Fluothane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluothane DMF submitted to regulatory agencies in the US is known as a USDMF. Fluothane USDMF includes data on Fluothane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluothane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluothane suppliers with USDMF on PharmaCompass.
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