01 3BASF
02 1Wyeth Pharmaceuticals Inc
03 1Blank
01 1ANTABUSE WITH RIBOFLAVIN TABLETS AND PLACEBO
02 1RIBOFLAVIN (BULK DRUG SUBSTANCE)
03 1RIBOFLAVIN 100
04 1RIBOFLAVIN, ACETYLATED
05 1RIBOFLAVINE
01 3Germany
02 1U.S.A
03 1Blank
01 5Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18846
Submission : 2005-10-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15576
Submission : 2001-08-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4407
Submission : 1981-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3541
Submission : 1979-05-31
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13
Submission : 1945-01-01
Status : Inactive
Type : II
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Corporate PDF
A Riboflavin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riboflavin, including repackagers and relabelers. The FDA regulates Riboflavin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riboflavin 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 Riboflavin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Riboflavin supplier is an individual or a company that provides Riboflavin active pharmaceutical ingredient (API) or Riboflavin finished formulations upon request. The Riboflavin suppliers may include Riboflavin API manufacturers, exporters, distributors and traders.
click here to find a list of Riboflavin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Riboflavin DMF (Drug Master File) is a document detailing the whole manufacturing process of Riboflavin active pharmaceutical ingredient (API) in detail. Different forms of Riboflavin DMFs exist exist since differing nations have different regulations, such as Riboflavin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riboflavin DMF submitted to regulatory agencies in the US is known as a USDMF. Riboflavin USDMF includes data on Riboflavin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riboflavin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riboflavin suppliers with USDMF on PharmaCompass.
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