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