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

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    Eluxadoline

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    PharmaCompass

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Alkem Laboratories (1)

    02 Aurobindo Pharma Limited (1)

    03 HONOUR LAB LTD (1)

    04 MSN Laboratories (1)

    05 Sun Pharmaceutical Industries Limited (1)

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    01 ELUXADOLINE (5)

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    01 India (5)

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    01 Active (5)

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    01 Complete (5)

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    ALKEM LABORATORIES LTD

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    ELUXADOLINE

    PDF Supplier PDF
    URL Supplier Web Content
    33372
    Active
    2019-01-02
    Complete
    2019-03-01
    2018-12-21
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    APITORIA PHARMA PRIVATE LTD

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    ELUXADOLINE

    PDF Supplier PDF
    URL Supplier Web Content
    33590
    Active
    2019-02-16
    Complete
    2019-03-13
    2019-02-15
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    HONOUR LAB LTD

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    ELUXADOLINE

    PDF Supplier PDF
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    33384
    Active
    2018-12-19
    Complete
    2019-02-21
    2018-12-12
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    MSN LIFE SCIENCES PRIVATE LTD

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    ELUXADOLINE

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    32148
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    2017-12-06
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    2019-04-12
    2019-01-28
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    SUN PHARMACEUTICAL INDUSTRIES LTD

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    ELUXADOLINE

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    33568
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    2019-03-26
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    2019-05-10
    2019-03-22
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    Looking for 864821-90-9 / Eluxadoline API manufacturers, exporters & distributors?

    Eluxadoline manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Eluxadoline

    Synonyms

    864821-90-9, Viberzi, Truberzi, Jnj-27018966, Eluxadoline [usan], Jnj 27018966

    Cas Number

    864821-90-9

    Unique Ingredient Identifier (UNII)

    45TPJ4MBQ1

    About Eluxadoline

    Eluxadoline is a mixed mu-opioid receptor agonist, kappa-opioid receptor agonist, and a-delta opioid receptor antagonist indicated for use in diarrhea-predominant irritable bowel syndrome (IBS-D). The mu-, kappa-, and delta-opioid receptors mediate endogenous and exogenous opioid response in the central nervous system and peripherally in the gastrointestinal system. Agonism of peripheral mu-opioid receptors results in reduced colonic motility, while antagonism of central delta-opioid receptors results in improved analgesia, making eluxadoline usable for the symptoms of both pain and diarrhea characteristic of IBS-D. Marketed under the tradename Viberzi (FDA), eluxadoline is an antimotility agent that decreases bowel contractions, inhibits colonic transit, and reduces uid/ion secretion resulting in improved symptoms of abdominal pain and reductions in the Bristol Stool Scale.

    Eluxadoline Manufacturers

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

    Eluxadoline Suppliers

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

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

    Eluxadoline USDMF

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

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

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

    Eluxadoline Manufacturers | Traders | Suppliers

    Eluxadoline Manufacturers, Traders, Suppliers 1
    27

    We have 5 companies offering Eluxadoline

    Get in contact with the supplier of your choice:

    1. Alkem Laboratories
    2. Aurobindo Pharma Limited
    3. HONOUR LAB LTD
    4. MSN Laboratories
    5. Sun Pharmaceutical Industries Limited
    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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