01 1Mitsubishi Corporation
02 1Blank
01 2SUCROSE MONOPALMITATE
01 1Japan
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6112
Submission : 1985-12-04
Status : Inactive
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 856
Submission : 1964-12-15
Status : Inactive
Type : IV
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A Sucrodet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucrodet, including repackagers and relabelers. The FDA regulates Sucrodet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucrodet 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 Sucrodet supplier is an individual or a company that provides Sucrodet active pharmaceutical ingredient (API) or Sucrodet finished formulations upon request. The Sucrodet suppliers may include Sucrodet API manufacturers, exporters, distributors and traders.
click here to find a list of Sucrodet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sucrodet DMF (Drug Master File) is a document detailing the whole manufacturing process of Sucrodet active pharmaceutical ingredient (API) in detail. Different forms of Sucrodet DMFs exist exist since differing nations have different regulations, such as Sucrodet USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sucrodet DMF submitted to regulatory agencies in the US is known as a USDMF. Sucrodet USDMF includes data on Sucrodet's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sucrodet USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sucrodet suppliers with USDMF on PharmaCompass.
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