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    List of Drug Master Files (KDMF) for Etravirine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Etravirine

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    01 Janssen Pharmaceutica N.V. (1)

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    Johnson & Johnson Innovative Medici...

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    Etravirine

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    Korea Janssen Co., Ltd.
    2008-05-07
    Number 217-3-ND
    Janssen Pharmaceutica N.V...
    Belgium
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    Looking for 269055-15-4 / Etravirine API manufacturers, exporters & distributors?

    Etravirine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Etravirine

    Synonyms

    269055-15-4, Intelence, Tmc-125, Tmc125, Etravirine (tmc125), Tmc 125

    Cas Number

    269055-15-4

    Unique Ingredient Identifier (UNII)

    0C50HW4FO1

    About Etravirine

    Etravirine is a diarylpyrimidine non-nucleoside reverse transcriptase inhibitor. Etravirine is designed to be active against HIV isolates with mutations that confer resistance to the two most commonly prescribed first-generation NNRTIs. It can bind the enzyme reverse transcriptase (RT) in multiple conformations, both for native and mutant RT, thereby blocking the enzymatic activity of RT.

    Etravirine Manufacturers

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

    Etravirine Suppliers

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

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

    Etravirine KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Etravirine Drug Master File in Korea (Etravirine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Etravirine. The MFDS reviews the Etravirine KDMF as part of the drug registration process and uses the information provided in the Etravirine KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Etravirine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Etravirine API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Etravirine suppliers with KDMF on PharmaCompass.

    Etravirine Manufacturers | Traders | Suppliers

    Etravirine Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Etravirine

    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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