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