01 1Sumitomo Pharma
01 1SMP-114
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18571
Submission : 2005-08-08
Status : Inactive
Type : II
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PharmaCompass offers a list of Rimacalib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Rimacalib manufacturer or Rimacalib supplier for your needs.
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A Rimacalib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimacalib, including repackagers and relabelers. The FDA regulates Rimacalib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimacalib 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 Rimacalib supplier is an individual or a company that provides Rimacalib active pharmaceutical ingredient (API) or Rimacalib finished formulations upon request. The Rimacalib suppliers may include Rimacalib API manufacturers, exporters, distributors and traders.
click here to find a list of Rimacalib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Rimacalib DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimacalib active pharmaceutical ingredient (API) in detail. Different forms of Rimacalib DMFs exist exist since differing nations have different regulations, such as Rimacalib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimacalib DMF submitted to regulatory agencies in the US is known as a USDMF. Rimacalib USDMF includes data on Rimacalib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimacalib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimacalib suppliers with USDMF on PharmaCompass.
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