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

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    Topiroxostat

    APIs // Active Pharmaceutical Ingredients

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    01 Tateyama Kasei Co., Ltd. (1)

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    01 Topiroxostat "Tateyama" (1)

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    01 Japan (1)

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    Tateyama Kasei Co., Ltd.

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    Topiroxostat “Tateyama”

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    224MF10098
    1133 Oe, Imizu City, Toyama Prefect...
    2013-04-15
    2012-05-08
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    Looking for 577778-58-6 / Topiroxostat API manufacturers, exporters & distributors?

    Topiroxostat manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Topiroxostat

    Synonyms

    577778-58-6, Fyx 051, Fyx-051, 4-(5-pyridin-4-yl-1h-1,2,4-triazol-3-yl)pyridine-2-carbonitrile, Topiroxostat [inn], 2-pyridinecarbonitrile, 4-[5-(4-pyridinyl)-1h-1,2,4-triazol-3-yl]-

    Cas Number

    577778-58-6

    Unique Ingredient Identifier (UNII)

    0J877412JV

    About Topiroxostat

    Topiroxostat is a selective xanthine oxidase inhibitor developed for treatment and management of hyperuricemia and gout. Xanthine oxidase, or xanthine oxidoreductase (XOR), regulates purine metabolism, and inhibition of the enzyme results in efficacious reduction of serum urate levels. Xanthine oxidase inhibitors are classified into two groups; purine analogs such as [DB00437] and [DB05262], and non-purine agents which includes topiroxostat. While [DB00437] is considered a first-line therapy in treating hyperuricemic conditions, it is often associated with side effects and ineffective in reducing uric acid levels under recommended dosing regimens. Renal complications are major comorbidities that limit the [DB00437] therapy as dose reductions are recommended. Topiroxostat and its metabolites are shown to be unaffected by renal complications, thus may be effective in patients with chronic kidney diseases. Approved for therapeutic use in Japan since 2013, topiroxostat is marketed under the name Topiloric and Uriadec and is orally administered twice daily.

    Topiroxostat Manufacturers

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

    Topiroxostat Suppliers

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

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

    Topiroxostat 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 Topiroxostat Drug Master File in Japan (Topiroxostat JDMF) empowers Topiroxostat 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 Topiroxostat JDMF during the approval evaluation for pharmaceutical products. At the time of Topiroxostat 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 Topiroxostat suppliers with JDMF on PharmaCompass.

    Topiroxostat Manufacturers | Traders | Suppliers

    Topiroxostat Manufacturers, Traders, Suppliers 1
    48

    We have 1 companies offering Topiroxostat

    Get in contact with the supplier of your choice:

    1. TATEYAMA KASEI CO LTD
    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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