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    Also known as: 923288-95-3, Nilotinib hydrochloride anhydrous, Nilotinib hcl, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride, Nilotinib (hydrochloride), K37n7byx3x
    Molecular Formula
    C28H23ClF3N7O
    Molecular Weight
    566.0  g/mol
    InChI Key
    VTGGYCCJUPYZSX-UHFFFAOYSA-N
    FDA UNII
    K37N7BYX3X
    Nilotinib
    Nilotinib Hydrochloride Anhydrous is the hydrochloride salt of nilotinib, an orally bioavailable aminopyrimidine-derivative Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity. Designed to overcome imatinib resistance, nilotinib binds to and stabilizes the inactive conformation of the kinase domain of the Abl protein of the Bcr-Abl fusion protein, resulting in the inhibition of the Bcr-Abl-mediated proliferation of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) cells. This agent also inhibits the receptor tyrosine kinases platelet-derived growth factor receptor (PDGF-R) and c-kit, a receptor tyrosine kinase mutated and constitutively activated in most gastrointestinal stromal tumors (GISTs). With a binding mode that is energetically more favorable than that of imatinib, nilotinib has been shown to have an approximately 20-fold increased potency in kinase and proliferation assays compared to imatinib.
    1 2D Structure

    Nilotinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrochloride
    2.1.2 InChI
    InChI=1S/C28H22F3N7O.ClH/c1-17-5-6-19(10-25(17)37-27-33-9-7-24(36-27)20-4-3-8-32-14-20)26(39)35-22-11-21(28(29,30)31)12-23(13-22)38-15-18(2)34-16-38;/h3-16H,1-2H3,(H,35,39)(H,33,36,37);1H
    2.1.3 InChI Key
    VTGGYCCJUPYZSX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=C(N=C3)C)NC4=NC=CC(=N4)C5=CN=CC=C5.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    K37N7BYX3X
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-methyl-n-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide

    2. Amn 107

    3. Amn-107

    4. Amn107

    5. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)

    6. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate

    7. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (1:1:2)

    8. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (1:2:2)

    9. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride, Hydrate (2:2:3)

    10. Nilotinib

    11. Nilotinib Dihydrochloride Dihydrate

    12. Nilotinib Hydrochloride Anhydrous

    13. Nilotinib Hydrochloride Dihydrate

    14. Nilotinib Hydrochloride Hydrate

    15. Nilotinib Hydrochloride Monohydrate

    16. Nilotinib Hydrochloride Sesquihydrate

    17. Tasigna

    2.3.2 Depositor-Supplied Synonyms

    1. 923288-95-3

    2. Nilotinib Hydrochloride Anhydrous

    3. Nilotinib Hcl

    4. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide Hydrochloride

    5. Nilotinib (hydrochloride)

    6. K37n7byx3x

    7. 4-methyl-n-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide;hydrochloride

    8. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, Hydrochloride (1:1)

    9. Nilotinib (as Hydrochloride)

    10. Unii-k37n7byx3x

    11. Amn 107 Hydrochloride

    12. Amn-107 Hcl

    13. Schembl434496

    14. Dtxsid60238968

    15. Bcp29532

    16. Hy-10159b

    17. S5205

    18. Ccg-270077

    19. Nilotinib Hydrochloride [vandf]

    20. Bn164657

    21. Nilotinib Hydrochloride Monohydrate- Bio-x

    22. Cs-0085192

    23. Nilotinib Hydrochloride [orange Book]

    24. Nilotinib Hydrochloride Anhydrous [who-dd]

    25. Q27281888

    26. Nilotinib Hcl;amn 107; Amn107; Amn-107; Nilotinib Hydrochloride Anhydrous

    27. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamidehydrochloride

    28. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(4-(pyridin-3-yl)pyrimidin-2-ylamino)benzamide Hydrochloride

    29. 4-methyl-n-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide Hydrochloride

    2.4 Create Date
    2007-04-02
    3 Chemical and Physical Properties
    Molecular Weight 566.0 g/mol
    Molecular Formula C28H23ClF3N7O
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count6
    Exact Mass565.1604706 g/mol
    Monoisotopic Mass565.1604706 g/mol
    Topological Polar Surface Area97.6 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity817
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2

    API Reference Price

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

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

    API | Excipient name

    Nilotinib

    Synonyms

    923288-95-3, Nilotinib hydrochloride anhydrous, Nilotinib hcl, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride, Nilotinib (hydrochloride), K37n7byx3x

    Cas Number

    923288-95-3

    Unique Ingredient Identifier (UNII)

    K37N7BYX3X

    About Nilotinib

    Nilotinib Hydrochloride Anhydrous is the hydrochloride salt of nilotinib, an orally bioavailable aminopyrimidine-derivative Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity. Designed to overcome imatinib resistance, nilotinib binds to and stabilizes the inactive conformation of the kinase domain of the Abl protein of the Bcr-Abl fusion protein, resulting in the inhibition of the Bcr-Abl-mediated proliferation of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) cells. This agent also inhibits the receptor tyrosine kinases platelet-derived growth factor receptor (PDGF-R) and c-kit, a receptor tyrosine kinase mutated and constitutively activated in most gastrointestinal stromal tumors (GISTs). With a binding mode that is energetically more favorable than that of imatinib, nilotinib has been shown to have an approximately 20-fold increased potency in kinase and proliferation assays compared to imatinib.

    Nilotinib Hydrochloride Monohydrate Manufacturers

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

    Nilotinib Hydrochloride Monohydrate Suppliers

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

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

    Nilotinib Hydrochloride Monohydrate USDMF

    A Nilotinib Hydrochloride Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nilotinib Hydrochloride Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Nilotinib Hydrochloride Monohydrate DMFs exist exist since differing nations have different regulations, such as Nilotinib Hydrochloride Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Nilotinib Hydrochloride Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Nilotinib Hydrochloride Monohydrate USDMF includes data on Nilotinib Hydrochloride Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nilotinib Hydrochloride Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with USDMF on PharmaCompass.

    Nilotinib Hydrochloride Monohydrate JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Nilotinib Hydrochloride Monohydrate Drug Master File in Japan (Nilotinib Hydrochloride Monohydrate JDMF) empowers Nilotinib Hydrochloride Monohydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Nilotinib Hydrochloride Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Nilotinib Hydrochloride Monohydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with JDMF on PharmaCompass.

    Nilotinib Hydrochloride Monohydrate KDMF

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

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

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

    click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with KDMF on PharmaCompass.

    Nilotinib Hydrochloride Monohydrate CEP

    A Nilotinib Hydrochloride Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Nilotinib Hydrochloride Monohydrate Certificate of Suitability (COS). The purpose of a Nilotinib Hydrochloride Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nilotinib Hydrochloride Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nilotinib Hydrochloride Monohydrate to their clients by showing that a Nilotinib Hydrochloride Monohydrate CEP has been issued for it. The manufacturer submits a Nilotinib Hydrochloride Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nilotinib Hydrochloride Monohydrate CEP holder for the record. Additionally, the data presented in the Nilotinib Hydrochloride Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nilotinib Hydrochloride Monohydrate DMF.

    A Nilotinib Hydrochloride Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nilotinib Hydrochloride Monohydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with CEP (COS) on PharmaCompass.

    Nilotinib Hydrochloride Monohydrate WC

    A Nilotinib Hydrochloride Monohydrate written confirmation (Nilotinib Hydrochloride Monohydrate WC) is an official document issued by a regulatory agency to a Nilotinib Hydrochloride Monohydrate manufacturer, verifying that the manufacturing facility of a Nilotinib Hydrochloride Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nilotinib Hydrochloride Monohydrate APIs or Nilotinib Hydrochloride Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Nilotinib Hydrochloride Monohydrate WC (written confirmation) as part of the regulatory process.

    click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.

    Nilotinib Hydrochloride Monohydrate NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nilotinib Hydrochloride Monohydrate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Nilotinib Hydrochloride Monohydrate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Nilotinib Hydrochloride Monohydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Nilotinib Hydrochloride Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nilotinib Hydrochloride Monohydrate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Nilotinib Hydrochloride Monohydrate suppliers with NDC on PharmaCompass.

    Nilotinib Hydrochloride Monohydrate GMP

    Nilotinib Hydrochloride Monohydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Nilotinib Hydrochloride Monohydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Nilotinib Hydrochloride Monohydrate GMP manufacturer or Nilotinib Hydrochloride Monohydrate GMP API supplier for your needs.

    Nilotinib Hydrochloride Monohydrate CoA

    A Nilotinib Hydrochloride Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Nilotinib Hydrochloride Monohydrate's compliance with Nilotinib Hydrochloride Monohydrate specifications and serves as a tool for batch-level quality control.

    Nilotinib Hydrochloride Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Nilotinib Hydrochloride Monohydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Nilotinib Hydrochloride Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Nilotinib Hydrochloride Monohydrate EP), Nilotinib Hydrochloride Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nilotinib Hydrochloride Monohydrate USP).

    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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