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

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    Alpelisib

    APIs // Active Pharmaceutical Ingredients

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Lek Pharmaceuticals d.d. (1)

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    Lek Pharmaceuticals

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    Alpelisib

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    URL Supplier Web Content
    Novartis Korea Co., Ltd.
    2021-05-12
    Wed196-21-ND
    Lek Pharmaceuticals d.d.
    Slovenian
    Kolodvorska cesta 27,1234...
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    Looking for 1217486-61-7 / Alpelisib API manufacturers, exporters & distributors?

    Alpelisib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Alpelisib

    Synonyms

    1217486-61-7, Byl-719, Byl719, Piqray, Nvp-byl719, Vijoice

    Cas Number

    1217486-61-7

    Unique Ingredient Identifier (UNII)

    08W5N2C97Q

    About Alpelisib

    Alpelisib is an orally bioavailable phosphatidylinositol 3-kinase (PI3K) inhibitor with potential antineoplastic activity. Alpelisib specifically inhibits PI3K in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.

    Alpelisib Manufacturers

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

    Alpelisib Suppliers

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

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

    Alpelisib KDMF

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

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

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

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

    Alpelisib Manufacturers | Traders | Suppliers

    Alpelisib Manufacturers, Traders, Suppliers 1
    17

    We have 1 companies offering Alpelisib

    Get in contact with the supplier of your choice:

    1. Lek Pharmaceuticals
    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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