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01 1HEXOBARBITAL, NF XIV
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2995
Submission : 1977-07-22
Status : Inactive
Type : II
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A Hexobarbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hexobarbital, including repackagers and relabelers. The FDA regulates Hexobarbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hexobarbital 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 Hexobarbital supplier is an individual or a company that provides Hexobarbital active pharmaceutical ingredient (API) or Hexobarbital finished formulations upon request. The Hexobarbital suppliers may include Hexobarbital API manufacturers, exporters, distributors and traders.
click here to find a list of Hexobarbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hexobarbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Hexobarbital active pharmaceutical ingredient (API) in detail. Different forms of Hexobarbital DMFs exist exist since differing nations have different regulations, such as Hexobarbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hexobarbital DMF submitted to regulatory agencies in the US is known as a USDMF. Hexobarbital USDMF includes data on Hexobarbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hexobarbital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hexobarbital suppliers with USDMF on PharmaCompass.
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