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

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    Voclosporin

    APIs // Active Pharmaceutical Ingredients

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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 Lonza Group (2)

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    01 VOCLOSPORIN (1)

    02 VOCLOSPORIN (IE-001) (1)

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    01 Switzerland (2)

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    LONZA AG

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    VOCLOSPORIN

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    33779
    Active
    2020-04-06
    N/A
    II
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    LONZA AG

    Contact Supplier
    • FDA
    • EDQM
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
    Post an Enquiry Post an Enquiry
    Flag Switzerland
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    Digital Content Digital Content

    VOCLOSPORIN (IE-001)

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    23335
    Inactive
    2009-12-02
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    Looking for 515814-01-4 / Voclosporin API manufacturers, exporters & distributors?

    Voclosporin manufacturers, exporters & distributors 1

    56

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

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

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

    API | Excipient name

    Voclosporin

    Synonyms

    515814-01-4, Lupkynis, Luveniq, Isatx-247, Voclosporin [usan], Isatx247

    Cas Number

    515814-01-4

    Unique Ingredient Identifier (UNII)

    2PN063X6B1

    About Voclosporin

    Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes. Voclosporin, marketed as Lupkynis, is a calcineurin-inhibitor immunosuppressant for the treatment of LN. This [cyclosporine] A analog was approved by the FDA on January 22, 2021 following promising results in clinical trials. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN. Voclosporin has demonstrated a more stable pharmacokinetic and pharmacodynamic relationship than cyclosporine, a higher potency than cyclosporine, and an improved metabolic profile when compared to older calcineurin inhibitors.

    Voclosporin Manufacturers

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

    Voclosporin Suppliers

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

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

    Voclosporin USDMF

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

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

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

    Voclosporin Manufacturers | Traders | Suppliers

    Voclosporin Manufacturers, Traders, Suppliers 1
    18

    We have 1 companies offering Voclosporin

    Get in contact with the supplier of your choice:

    1. Lonza Group
    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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