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

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    Lorlatinib

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    DOSSIERs // Finished Dosage Forms

    GLOBAL SALES INFORMATION

    PATENTS

    DIGITAL CONTENT

    PharmaCompass

    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 Pfizer Ireland Pharmaceuticals (1)

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    01 Pfizer Pharmaceuticals Korea Co., Ltd. (1)

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    01 Rolatinib (1)

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    01 U.S.A (1)

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    Pfizer Inc

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    Rolatinib

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    Pfizer Pharmaceuticals Korea Co., Ltd.
    2021-11-30
    Wed87-30-ND
    Pfizer Ireland Pharmaceut...
    Ireland
    Ringaskiddy API Plant, PO...
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    Looking for 1454846-35-5 / Lorlatinib API manufacturers, exporters & distributors?

    Lorlatinib manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Lorlatinib

    Synonyms

    1454846-35-5, Pf-06463922, Loratinib, Lorbrena, Pf06463922, Pf 06463922

    Cas Number

    1454846-35-5

    Unique Ingredient Identifier (UNII)

    OSP71S83EU

    About Lorlatinib

    Lorlatinib is an orally available, ATP-competitive inhibitor of the receptor tyrosine kinases, anaplastic lymphoma kinase (ALK) and C-ros oncogene 1 (Ros1), with potential antineoplastic activity. Upon administration, lorlatinib binds to and inhibits both ALK and ROS1 kinases. The kinase inhibition leads to disruption of ALK- and ROS1-mediated signaling and eventually inhibits tumor cell growth in ALK- and ROS1-overexpressing tumor cells. In addition, PF-06463922 is able to cross the blood brain barrier. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development; ALK dysregulation and gene rearrangements are associated with a series of tumors. ROS1, overexpressed in certain cancer cells, plays a key role in cell growth and survival of cancer cells.

    Lorlatinib Manufacturers

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

    Lorlatinib Suppliers

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

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

    Lorlatinib KDMF

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

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

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

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

    Lorlatinib Manufacturers | Traders | Suppliers

    Lorlatinib Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Lorlatinib

    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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