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    List of Drug Master Files (JDMF) for Avacopan Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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    Avacopan

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    Hovione LLC

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    abacopan drug substance

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    303MF10022
    40 Lake Drive, East Windsor, NJ0852...
    2021-09-09
    2021-01-28
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    Looking for 1346623-17-3 / Avacopan API manufacturers, exporters & distributors?

    Avacopan manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Avacopan

    Synonyms

    1346623-17-3, Ccx168, Avacopan [inn], Avacopan [usan], Ccx-168, O880nm097t

    Cas Number

    1346623-17-3

    Unique Ingredient Identifier (UNII)

    O880NM097T

    About Avacopan

    Anti-neutrophil cytoplasmic (auto)antibody (ANCA)-associated vasculitis (AAV) is a rare (estimated incidence of 3 cases per 100,000 per year) form of "pauci-immune" systemic small-vessel vasculitis typified by the presence of ANCAs in the serum. The full spectrum of AAV includes granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), and drug-induced AAV. AAV may be associated with necrotizing and crescentic glomerulonephritis (NCGN). Despite complex pathophysiology, studies over the past ~2 decades have identified a key role for the alternative complement pathway and, in particular, the interaction between the anaphylatoxin fragment C5a and its cognate C5aR receptor in AAV. Avacopan (formerly CCX168) is an allosteric C5aR antagonist indicated for use in AAV. Avacopan was granted FDA approval on October 8, 2021, and is currently marketed under the name TAVNEOS by ChemoCentryx, Inc.

    Avacopan Manufacturers

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

    Avacopan Suppliers

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

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

    Avacopan JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Avacopan Drug Master File in Japan (Avacopan JDMF) empowers Avacopan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Avacopan JDMF during the approval evaluation for pharmaceutical products. At the time of Avacopan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Avacopan suppliers with JDMF on PharmaCompass.

    Avacopan Manufacturers | Traders | Suppliers

    Avacopan Manufacturers, Traders, Suppliers 1
    69

    We have 1 companies offering Avacopan

    Get in contact with the supplier of your choice:

    1. Hovione
    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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