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