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

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    Doravirine

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    01 Hetero Drugs (1)

    02 Viatris (1)

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    01 DORAVIRINE (1)

    02 DORAVIRINE PREMIX (1)

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    02 U.S.A (1)

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    HETERO LABS LTD

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    DORAVIRINE PREMIX

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    37216
    Active
    2022-06-23
    Complete
    2022-08-09
    2022-06-17
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    MYLAN LABORATORIES LTD

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    DORAVIRINE

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    38795
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    2023-10-06
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    Looking for 1338225-97-0 / Doravirine API manufacturers, exporters & distributors?

    Doravirine manufacturers, exporters & distributors 1

    43

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

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

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

    API | Excipient name

    Doravirine

    Synonyms

    1338225-97-0, Mk-1439, Pifeltro, 3-chloro-5-((1-((4-methyl-5-oxo-4,5-dihydro-1h-1,2,4-triazol-3-yl)methyl)-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl)oxy)benzonitrile, 3-chloro-5-[1-[(4-methyl-5-oxo-1h-1,2,4-triazol-3-yl)methyl]-2-oxo-4-(trifluoromethyl)pyridin-3-yl]oxybenzonitrile, Mk1439

    Cas Number

    1338225-97-0

    Unique Ingredient Identifier (UNII)

    913P6LK81M

    About Doravirine

    Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines. Doravirine is available by itself or as a combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg). Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic treatments available for the management of HIV-1 infection.

    Doravirine Manufacturers

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

    Doravirine Suppliers

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

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

    Doravirine USDMF

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

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

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

    Doravirine Manufacturers | Traders | Suppliers

    Doravirine Manufacturers, Traders, Suppliers 1
    80

    We have 2 companies offering Doravirine

    Get in contact with the supplier of your choice:

    1. Hetero Drugs
    2. Viatris
    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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