01 1Sumitomo Chemical
01 1SUMITHRIN
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5631
Submission : 1984-11-30
Status : Inactive
Type : II
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A Sumithrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sumithrin, including repackagers and relabelers. The FDA regulates Sumithrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sumithrin 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 Sumithrin supplier is an individual or a company that provides Sumithrin active pharmaceutical ingredient (API) or Sumithrin finished formulations upon request. The Sumithrin suppliers may include Sumithrin API manufacturers, exporters, distributors and traders.
click here to find a list of Sumithrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sumithrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Sumithrin active pharmaceutical ingredient (API) in detail. Different forms of Sumithrin DMFs exist exist since differing nations have different regulations, such as Sumithrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sumithrin DMF submitted to regulatory agencies in the US is known as a USDMF. Sumithrin USDMF includes data on Sumithrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sumithrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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