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    List of Drug Master Files (DMF) of Simeprevir Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Simeprevir

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    01 Johnson & Johnson Innovative Medicine (1)

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    01 SIMEPREVIR (R494617) DRUG SUBSTANCE (1)

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    JANSSEN PHARMACEUTICA NV

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    SIMEPREVIR (R494617) DRUG SUBSTANCE

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    2013-03-22
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    Looking for 923604-59-5 / Simeprevir API manufacturers, exporters & distributors?

    Simeprevir manufacturers, exporters & distributors 1

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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, Price,and more, enabling you to easily find the right Simeprevir manufacturer or Simeprevir supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Simeprevir manufacturer or Simeprevir supplier.

    PharmaCompass also assists you with knowing the Simeprevir API Price utilized in the formulation of products. Simeprevir API Price is not always fixed or binding as the Simeprevir Price is obtained through a variety of data sources. The Simeprevir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Simeprevir

    Synonyms

    Tmc435, 923604-59-5, Tmc435350, Tmc-435, Olysio, Tmc 435

    Cas Number

    923604-59-5

    Unique Ingredient Identifier (UNII)

    9WS5RD66HZ

    About Simeprevir

    Oral HCV-PROTEASE INHIBITOR effective against hepatitis C virus (HCV) serine protease NS3/4A. It is used in the treatment of chronic hepatitis C (Antivirals) genotype 1 infection in adults with compensated liver disease, including CIRRHOSIS.

    Simeprevir Manufacturers

    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, COA and API Price related information on PhamaCompass.

    Simeprevir Suppliers

    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, COA and API Price related information on PharmaCompass.

    Simeprevir USDMF

    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.

    Simeprevir Manufacturers | Traders | Suppliers

    Simeprevir Manufacturers, Traders, Suppliers 1
    77

    We have 1 companies offering Simeprevir

    Get in contact with the supplier of your choice:

    1. Johnson & Johnson Innovative Medicine
    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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