01 1Siegfried AG
01 1SECOBARBITAL SODIUM USP
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1050
Submission : 1967-03-22
Status : Inactive
Type : II
28
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A BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT, including repackagers and relabelers. The FDA regulates BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT DMF (Drug Master File) is a document detailing the whole manufacturing process of BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT active pharmaceutical ingredient (API) in detail. Different forms of BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT DMFs exist exist since differing nations have different regulations, such as BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT DMF submitted to regulatory agencies in the US is known as a USDMF. BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT USDMF includes data on BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BARBITURIC ACID, 5-ALLYL-5-(1-METHYLBUTYL)-, SODIUM SALT USDMF is kept confidential to protect the manufacturer’s intellectual property.
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