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

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    Lemborexant

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    MOEHS IBERICA SL

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    • FDA
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    Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.
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    LEMBOREXANT

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    38219
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    2023-03-27
    N/A
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    Moehs Iberica CB

    CPhI North America

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    Looking for 1369764-02-2 / Lemborexant API manufacturers, exporters & distributors?

    Lemborexant manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Lemborexant

    Synonyms

    1369764-02-2, Dayvigo, E-2006, E2006, 0k5743g68x, (1r,2s)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-n-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide

    Cas Number

    1369764-02-2

    Unique Ingredient Identifier (UNII)

    0K5743G68X

    About Lemborexant

    Lemborexant is a novel dual orexin receptor antagonist used in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Recent research in the field of sleep disorders has revealed that insomnia is likely driven not by the inability of the brain to "switch on" sleep-related circuits, but rather an inability to "switch-off" wake-promoting circuits. Whereas historically popular pharmacologic treatments for insomnia (e.g. [zopiclone], [zolpidem], benzodiazepines) focus on enhancing sleep drive via modulation of GABA and melatonin receptors, lemborexant and other orexin antagonists (e.g. [suvorexant]) act to counteract inappropriate wakefulness. This novel mechanism of action offers potential advantages over classic hypnotic agents, including a more favorable adverse effect profile and potentially greater efficacy, and may signal the beginning of a new wave of treatment options for patients suffering from insomnia.

    Lemborexant Manufacturers

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

    Lemborexant Suppliers

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

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

    Lemborexant USDMF

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

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

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

    Lemborexant Manufacturers | Traders | Suppliers

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

    Get in contact with the supplier of your choice:

    1. Moehs Iberica
    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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