01 1Johnson & Johnson Innovative Medicine
01 1SIMEPREVIR (R494617) DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26864
Submission : 2013-03-22
Status : Inactive
Type : II
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PharmaCompass offers a list of Simeprevir 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 Simeprevir manufacturer or Simeprevir supplier for your needs.
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A Simeprevir sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simeprevir sodium, including repackagers and relabelers. The FDA regulates Simeprevir sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simeprevir sodium 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 Simeprevir sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Simeprevir sodium supplier is an individual or a company that provides Simeprevir sodium active pharmaceutical ingredient (API) or Simeprevir sodium finished formulations upon request. The Simeprevir sodium suppliers may include Simeprevir sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Simeprevir sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Simeprevir sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Simeprevir sodium active pharmaceutical ingredient (API) in detail. Different forms of Simeprevir sodium DMFs exist exist since differing nations have different regulations, such as Simeprevir sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Simeprevir sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Simeprevir sodium USDMF includes data on Simeprevir sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Simeprevir sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Simeprevir sodium suppliers with USDMF on PharmaCompass.
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