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

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    Telaprevir

    APIs // Active Pharmaceutical Ingredients

    INTERMEDIATES

    DOSSIERs // Finished Dosage Forms

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    01 Glenmark Life Sciences (1)

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    01 TELAPREVIR (1)

    02 TELAPREVIR DRUG SUBSTANCE (R600109) (1)

    03 TELAPREVIR SPRAY DRIED DISPERSION (INTERMEDIATE DRUG PRODUCT) (1)

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    GLENMARK LIFE SCIENCES LTD

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      TELAPREVIR

      PDF Supplier PDF
      URL Supplier Web Content
      27665
      Active
      2014-07-30
      Complete
      2014-10-28
      2013-12-05
      II
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      JANSSEN PHARMACEUTICA NV

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      • EDQM
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      TELAPREVIR SPRAY DRIED DISPERSION (INTERMEDIATE DRUG PRODUCT)

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      23788
      Inactive
      2010-06-24
      N/A
      II
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      JANSSEN PHARMACEUTICA NV

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      • EDQM
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      TELAPREVIR DRUG SUBSTANCE (R600109)

      PDF Supplier PDF
      URL Supplier Web Content
      23787
      Inactive
      2010-06-24
      N/A
      II
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      Looking for 402957-28-2 / Telaprevir API manufacturers, exporters & distributors?

      Telaprevir manufacturers, exporters & distributors 1

      45

      PharmaCompass offers a list of Telaprevir 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 Telaprevir manufacturer or Telaprevir supplier for your needs.

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

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

      API | Excipient name

      Telaprevir

      Synonyms

      402957-28-2, Vx-950, Incivek, Telaprevir (vx-950), Incivo, Mp-424

      Cas Number

      402957-28-2

      Unique Ingredient Identifier (UNII)

      655M5O3W0U

      About Telaprevir

      Telaprevir is an orally available peptidomimetic small molecule with activity against hepatitis C virus (HCV). Telaprivir is a selective protease inhibitor that targets the viral HCV NS3-4A serine protease and disrupts processing of viral proteins and formation of a viral replication complex.

      Telaprevir Manufacturers

      A Telaprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Telaprevir, including repackagers and relabelers. The FDA regulates Telaprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Telaprevir 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 Telaprevir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

      Telaprevir Suppliers

      A Telaprevir supplier is an individual or a company that provides Telaprevir active pharmaceutical ingredient (API) or Telaprevir finished formulations upon request. The Telaprevir suppliers may include Telaprevir API manufacturers, exporters, distributors and traders.

      click here to find a list of Telaprevir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

      Telaprevir USDMF

      A Telaprevir DMF (Drug Master File) is a document detailing the whole manufacturing process of Telaprevir active pharmaceutical ingredient (API) in detail. Different forms of Telaprevir DMFs exist exist since differing nations have different regulations, such as Telaprevir USDMF, ASMF (EDMF), JDMF, CDMF, etc.

      A Telaprevir DMF submitted to regulatory agencies in the US is known as a USDMF. Telaprevir USDMF includes data on Telaprevir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Telaprevir USDMF is kept confidential to protect the manufacturer’s intellectual property.

      click here to find a list of Telaprevir suppliers with USDMF on PharmaCompass.

      Telaprevir Manufacturers | Traders | Suppliers

      Telaprevir Manufacturers, Traders, Suppliers 1
      76

      We have 2 companies offering Telaprevir

      Get in contact with the supplier of your choice:

      1. Glenmark Life Sciences
      2. 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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