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

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    Olmutinib

    APIs // Active Pharmaceutical Ingredients

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    01 Hanmi Fine Chemical Co., Ltd. (1)

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    01 Hanmi Fine Chemical Co., Ltd. (1)

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    01 Olmutinib hydrochloride monohydrate (1)

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    01 South Korea (1)

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    Hanmi Pharmaceutical

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    Olmutinib hydrochloride monohydrate

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    Hanmi Fine Chemical Co., Ltd.
    2016-04-22
    1444-4-ND
    Hanmi Fine Chemical Co., ...
    South Korea
    57 Gyeongje-ro, Siheung-s...
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    Looking for 1353550-13-6 / Olmutinib API manufacturers, exporters & distributors?

    Olmutinib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Olmutinib

    Synonyms

    1353550-13-6, Hm61713, Bi 1482694, 1802181-20-9, Olmutinib [inn], Hm-61713

    Cas Number

    1353550-13-6

    Unique Ingredient Identifier (UNII)

    CHL9B67L95

    About Olmutinib

    Olmutinib is an orally available small molecule, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) with potential antineoplastic activity. Olmutinib binds to and inhibits mutant forms of EGFR, thereby leading to cell death of EGFR-expressing tumor cells. As this agent is selective towards mutant forms of EGFR, its toxicity profile may be reduced as compared to non-selective EGFR inhibitors which also inhibit the EGFR wild type form.

    Olmutinib Manufacturers

    A Olmutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olmutinib, including repackagers and relabelers. The FDA regulates Olmutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olmutinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    Olmutinib Suppliers

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

    Olmutinib KDMF

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

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

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

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

    Olmutinib Manufacturers | Traders | Suppliers

    Olmutinib Manufacturers, Traders, Suppliers 1
    95

    We have 1 companies offering Olmutinib

    Get in contact with the supplier of your choice:

    1. Hanmi Pharmaceutical
    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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