01 1Siegfried AG
02 1Blank
01 2MEPHOBARBITAL
01 1Switzerland
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5643
Submission : 1984-12-20
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5596
Submission : 1984-11-14
Status : Inactive
Type : II
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A Mephobarbital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mephobarbital, including repackagers and relabelers. The FDA regulates Mephobarbital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mephobarbital 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 Mephobarbital supplier is an individual or a company that provides Mephobarbital active pharmaceutical ingredient (API) or Mephobarbital finished formulations upon request. The Mephobarbital suppliers may include Mephobarbital API manufacturers, exporters, distributors and traders.
click here to find a list of Mephobarbital suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mephobarbital DMF (Drug Master File) is a document detailing the whole manufacturing process of Mephobarbital active pharmaceutical ingredient (API) in detail. Different forms of Mephobarbital DMFs exist exist since differing nations have different regulations, such as Mephobarbital USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mephobarbital DMF submitted to regulatory agencies in the US is known as a USDMF. Mephobarbital USDMF includes data on Mephobarbital's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mephobarbital USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mephobarbital suppliers with USDMF on PharmaCompass.
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