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    List of Drug Master Files (KDMF) for Isavuconazonium Sulfate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Isavuconazonium Sulfate

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    01 Hovione FarmaCiencia S.A. (1)

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    Pfizer Inc

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    Isavuconazonium sulfate

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    Pfizer Pharmaceuticals Korea Co., Ltd.
    2020-01-29
    Wed87-26-ND
    Hovione FarmaCiencia S.A.
    Portugal
    Sete Casas, Loures, 2674-...
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    Looking for 946075-13-4 / Isavuconazonium Sulfate API manufacturers, exporters & distributors?

    Isavuconazonium Sulfate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Isavuconazonium Sulfate

    Synonyms

    946075-13-4, Cresemba, Isavuconazonium (sulfate), Bal-8557-002, Isavuconazonium sulfate [usan], Chebi:85977

    Cas Number

    946075-13-4

    Unique Ingredient Identifier (UNII)

    31Q44514JV

    About Isavuconazonium Sulfate

    Isavuconazonium Sulfate is the sulfate ester form of isavuconazonium, a prodrug of the triazole antifungal agent isavuconazole, with broad-spectrum antifungal activity. Upon administration, isavuconazonium sulfate is hydrolyzed by plasma esterases to yield the active moiety isavuconazole. Isavuconazole binds to and inhibits the fungal cytochrome P450 family enzyme lanosterol 14-alpha-demethylase (CYP51), which catalyzes the demethylation of lanosterol to yield ergosterol, an important component of the fungal cell membrane. Inhibition of CYP51 leads to a decrease in fungal ergosterol production and disrupts synthesis of the fungal cell membrane, which decreases membrane integrity, increases cell membrane permeability and promotes the loss of essential intracellular elements. This results in fungal cell lysis and death.

    Isavuconazonium Sulfate Manufacturers

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

    Isavuconazonium Sulfate Suppliers

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

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

    Isavuconazonium Sulfate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Isavuconazonium Sulfate Drug Master File in Korea (Isavuconazonium Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isavuconazonium Sulfate. The MFDS reviews the Isavuconazonium Sulfate KDMF as part of the drug registration process and uses the information provided in the Isavuconazonium Sulfate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Isavuconazonium Sulfate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Isavuconazonium Sulfate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Isavuconazonium Sulfate suppliers with KDMF on PharmaCompass.

    Isavuconazonium Sulfate Manufacturers | Traders | Suppliers

    Isavuconazonium Sulfate Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Isavuconazonium Sulfate

    Get in contact with the supplier of your choice:

    1. Pfizer Inc
    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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