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01 1MANUFACTURE OF SODIUM BARBITAL
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1165
Submission : 1968-04-18
Status : Inactive
Type : II
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A Barbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Barbital, including repackagers and relabelers. The FDA regulates Barbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Barbital 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 Barbital manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Barbital supplier is an individual or a company that provides Barbital active pharmaceutical ingredient (API) or Barbital finished formulations upon request. The Barbital suppliers may include Barbital API manufacturers, exporters, distributors and traders.
click here to find a list of Barbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Barbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Barbital active pharmaceutical ingredient (API) in detail. Different forms of Barbital DMFs exist exist since differing nations have different regulations, such as Barbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Barbital DMF submitted to regulatory agencies in the US is known as a USDMF. Barbital USDMF includes data on Barbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Barbital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Barbital suppliers with USDMF on PharmaCompass.
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