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

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    Darolutamide

    APIs // Active Pharmaceutical Ingredients

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    01 Fermion Oy (1)

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    Fermion Oy

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    Darorutamide

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    Bayer Korea Co., Ltd.
    2020-05-27
    Wed212-7-ND
    Fermion Oy
    Finland
    Orioninkatu 2, Hanko FI-1...
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    CPhI North America

    Booth #1117

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    Looking for 1297538-32-9 / Darolutamide API manufacturers, exporters & distributors?

    Darolutamide manufacturers, exporters & distributors 1

    49

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

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

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

    API | Excipient name

    Darolutamide

    Synonyms

    Odm-201, 1297538-32-9, Bay-1841788, Nubeqa, Bay1841788, Darolutamide [usan]

    Cas Number

    1297538-32-9

    Unique Ingredient Identifier (UNII)

    X05U0N2RCO

    About Darolutamide

    Darolutamide is a formulation containing an androgen receptor (AR) antagonist with potential antineoplastic activity. Darolutamide binds to ARs in target tissues; subsequently, inhibiting androgen-induced receptor activation and facilitating the formation of inactive complexes that cannot translocate to the nucleus. This prevents binding to and transcription of AR-responsive genes that regulate prostate cancer cell proliferation. This ultimately leads to an inhibition of growth in AR-expressing prostate cancer cells.

    Darolutamide Manufacturers

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

    Darolutamide Suppliers

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

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

    Darolutamide KDMF

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

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

    After submitting a Darolutamide 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 Darolutamide API can apply through the Korea Drug Master File (KDMF).

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

    Darolutamide Manufacturers | Traders | Suppliers

    Darolutamide Manufacturers, Traders, Suppliers 1
    53

    We have 1 companies offering Darolutamide

    Get in contact with the supplier of your choice:

    1. Fermion Oy
    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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