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    Chemistry

    Click the arrow to open the dropdown
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    Also known as: 341031-54-7, Sutent, Su011248 l-malate salt, Sunitinib malate [usan], Pha-290940ad, Su010398
    Molecular Formula
    C26H33FN4O7
    Molecular Weight
    532.6  g/mol
    InChI Key
    LBWFXVZLPYTWQI-IPOVEDGCSA-N
    FDA UNII
    LVX8N1UT73
    Sunitinib
    An indole and pyrrole derivative that inhibits VEGFR-2 and PDGFR BETA RECEPTOR TYROSINE KINASES. It is used as an antineoplastic agent for the treatment of GASTROINTESTINAL STROMAL TUMORS, and for treatment of advanced or metastatic RENAL CELL CARCINOMA.
    1 2D Structure

    Sunitinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-2-oxo-1H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide;(2S)-2-hydroxybutanedioic acid
    2.1.2 InChI
    InChI=1S/C22H27FN4O2.C4H6O5/c1-5-27(6-2)10-9-24-22(29)20-13(3)19(25-14(20)4)12-17-16-11-15(23)7-8-18(16)26-21(17)28;5-2(4(8)9)1-3(6)7/h7-8,11-12,25H,5-6,9-10H2,1-4H3,(H,24,29)(H,26,28);2,5H,1H2,(H,6,7)(H,8,9)/b17-12-;/t;2-/m.0/s1
    2.1.3 InChI Key
    LBWFXVZLPYTWQI-IPOVEDGCSA-N
    2.1.4 Canonical SMILES
    CCN(CC)CCNC(=O)C1=C(NC(=C1C)C=C2C3=C(C=CC(=C3)F)NC2=O)C.C(C(C(=O)O)O)C(=O)O
    2.1.5 Isomeric SMILES
    CCN(CC)CCNC(=O)C1=C(NC(=C1C)/C=C\2/C3=C(C=CC(=C3)F)NC2=O)C.C([C@@H](C(=O)O)O)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    LVX8N1UT73
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-(5-fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1h-pyrrole-3-carboxylic Acid (2-diethylaminoethyl)amide

    2. Su 011248

    3. Su 11248

    4. Su-011248

    5. Su-11248

    6. Su011248

    7. Su11248

    8. Sunitinib

    9. Sutent

    2.3.2 Depositor-Supplied Synonyms

    1. 341031-54-7

    2. Sutent

    3. Su011248 L-malate Salt

    4. Sunitinib Malate [usan]

    5. Pha-290940ad

    6. Su010398

    7. Sunitinib L-malate

    8. Su-011248 L-malate Salt

    9. Lvx8n1ut73

    10. Su-010398

    11. (z)-n-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (s)-2-hydroxysuccinate

    12. Su 11248

    13. N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-2-oxo-1h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide;(2s)-2-hydroxybutanedioic Acid

    14. Butanedioic Acid, Hydroxy-, (2s)-, Compd. With N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

    15. N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (2s)-hydroxybutanedioate

    16. (2s)-2-hydroxybutanedioic Acid; N-[2-(diethylamino)ethyl]-5-{[(3z)-5-fluoro-2-oxo-2,3-dihydro-1h-indol-3-ylidene]methyl}-2,4-dimethyl-1h-pyrrole-3-carboxamide

    17. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

    18. Su 011248

    19. Unii-lvx8n1ut73

    20. Butanedioic Acid, 2-hydroxy-, (2s)-, Compd. With N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

    21. Mfcd08282795

    22. Pdgf Tk Antagonist

    23. Sutent (tn)

    24. Sunitinib Malate- Bio-x

    25. Sutent (tn) (pfizer)

    26. Sunitinib Malate (sutent)

    27. Chembl1567

    28. Su 11248 (malate)

    29. Su-11248 L-malate Salt

    30. Sunitinib Malate [mi]

    31. Sunitinib Malate (jan/usan)

    32. Sunitinib Malate [jan]

    33. Schembl1258610

    34. Schembl1772213

    35. Dtxsid4046492

    36. Sunitinib Malate [vandf]

    37. Sunitinib Malate [mart.]

    38. Pnu-290940ad

    39. Sunitinib Malate [who-dd]

    40. Hms3261h09

    41. Sunitinib Malate, >=98% (hplc)

    42. Tox21_500514

    43. Nsc736511

    44. S1042

    45. Su-11248j

    46. Akos005145765

    47. Akos025149097

    48. Sunitinib Malate (sunitinib L-malate)

    49. Sunitinib Malate [orange Book]

    50. Ccg-221818

    51. Cs-0177

    52. Ks-5023

    53. Ncgc00261199-01

    54. Bs164428

    55. Hy-10255

    56. Am20090634

    57. Sw219407-1

    58. D06402

    59. 031s547

    60. A822079

    61. J-019449

    62. Q27283213

    63. Sunitinib Malate

    64. 341031-54-7

    65. Sutent

    66. Su-11248

    67. Sunitinib

    68. (2s)-2-hydroxybutanedioic Acid Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

    69. (z)-n-(2-(diethylamino)ethyl)-5-((5-fluoro-2-oxoindolin-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide(s)-2-hydroxysuccinate

    70. 1h-pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl)-2,4-dimethyl-, (2s)-hydroxybutanedioate (1:1)

    71. 1h-pyrrole-3-carboxamide,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-, (2s)-hydroxybutanedioate (1:1)

    72. 1h-pyrrole-3-carboxamide,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-, Malate Salt

    73. Butanedioic Acid, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1)

    74. Butanedioic Acid, (2s)-, Compd. With N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidene)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (1:1) (ca Index Name)

    75. N-(2-diethylamino)ethyl)-5-((z)-(5-fluoro-2-oxo-1,2-dihydro-3h-indol-3-ylidene)methyl)-2,4-dimethyl-1h-pyrrole-3-carboxamide Hydrogen (2s)-2-hydroxybutanedioate

    76. N-[2-(diethylamino)ethyl]-5-[(z)-(5-fluoro-1,2-dihydro-2-oxo-3h-indol-3-ylidine)methyl]-2,4-dimethyl-1h-pyrrole-3-carboxamide (2s)-2-hydroxybutanedioate Salt

    2.4 Create Date
    2006-04-29
    3 Chemical and Physical Properties
    Molecular Weight 532.6 g/mol
    Molecular Formula C26H33FN4O7
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count10
    Exact Mass532.23332757 g/mol
    Monoisotopic Mass532.23332757 g/mol
    Topological Polar Surface Area172 Ų
    Heavy Atom Count38
    Formal Charge0
    Complexity765
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameSunitinib malate
    Drug LabelSUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)meth...
    Active IngredientSunitinib malate
    Dosage FormCapsule
    RouteOral
    Strengtheq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base
    Market StatusPrescription
    CompanyMylan Pharms

    2 of 2  
    Drug NameSunitinib malate
    Drug LabelSUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)meth...
    Active IngredientSunitinib malate
    Dosage FormCapsule
    RouteOral
    Strengtheq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base
    Market StatusPrescription
    CompanyMylan Pharms

    4.2 Drug Indication

    * Gastrointestinal stromal tumour (GIST):

    Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance.

    * Metastatic renal cell carcinoma (MRCC):

    Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.

    * Pancreatic neuroendocrine tumours (pNET):

    Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.

    Experience with Sutent as first-line treatment is limited (see section 5. 1).

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Angiogenesis Inhibitors

    Agents and endogenous substances that antagonize or inhibit the development of new blood vessels. (See all compounds classified as Angiogenesis Inhibitors.)

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    Protein Kinase Inhibitors

    Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Protein Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
    5.3 ATC Code

    L01EX01

    API Reference Price

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(INDIA) PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"19.95","actualQuantity":"19.954","unit":"KGS","unitRateFc":"3500","totalValueFC":"71690.9","currency":"USD","unitRateINR":"280294.1","date":"16-Jun-2022","totalValueINR":"5592988.56","totalValueInUsd":"71690.9","indian_port":"BANGALORE AIR","hs_no":"29349990","bill_no":"9132181","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"N0 116\/117, KIADB INDUSTRIAL AREA, ,JIGANI 2ND PHASE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666895400,"product":"SUNITINIB MALATE","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"SHANDONG ANHONG PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"0.31","actualQuantity":"0.31","unit":"KGS","unitRateFc":"6000","totalValueFC":"1896.5","currency":"USD","unitRateINR":"503400","date":"28-Oct-2022","totalValueINR":"156054","totalValueInUsd":"1896.5","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"3062558","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677868200,"product":"SUNITINIB MALATE","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"3500","totalValueFC":"1066","currency":"USD","unitRateINR":"292250","date":"04-Mar-2023","totalValueINR":"87675","totalValueInUsd":"1066","indian_port":"HYDERABAD AIR","hs_no":"29333990","bill_no":"4897109","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678905000,"product":"SUNITINIB MALATE SP-CFTO-023323V1 EFF 03-06-21","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"MALTA (VALLETTA)","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"3050.4","totalValueFC":"61934.9","currency":"USD","unitRateINR":"254708.4","date":"16-Mar-2023","totalValueINR":"5094168","totalValueInUsd":"61934.9","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"1000543","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"N\/A","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696530600,"product":"(REIMPORT REJECTED GOODS) SUNITINIB MALATE IH (BATCH # SU21110008)","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"ACTAVIS INC","supplierCountry":"INDIA","foreign_port":"TAIYUAN","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"7.32","actualQuantity":"7.3208","unit":"KGS","unitRateFc":"6000","totalValueFC":"44554.4","currency":"USD","unitRateINR":"506533.2","date":"06-Oct-2023","totalValueINR":"3708228.51","totalValueInUsd":"44554.4","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"8165300","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"NO.30, CHENGGONG 1ST RD, SINSING VILLAGE, NANTOU CITY, NANTOU COUNTY 540, TAIWAN Taiwan, Province of China","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698431400,"product":"SUNITINIB MALATE (FORM-II) BATCH NO ACSNTNF017 (RE-IMPORT)","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SYNTHON B.V.","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"2.44","actualQuantity":"2.439","unit":"KGS","unitRateFc":"25000","totalValueFC":"67537.3","currency":"EUR","unitRateINR":"2304665.8","date":"28-Oct-2023","totalValueINR":"5621079.86","totalValueInUsd":"67537.3","indian_port":"Bombay Air","hs_no":"29337990","bill_no":"8522031","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CALLE CASTELLO,108830 SANT BOI DE LIOBREGATSPAIN SPAIN","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702492200,"product":"SUNITINIB MALATE API","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"MEDICHEM MANUFACTURING (MALTA)LTD","supplierCountry":"MALTA","foreign_port":"MALTA (VALLETTA)","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"31.00","actualQuantity":"31","unit":"KGS","unitRateFc":"3127","totalValueFC":"98167.7","currency":"USD","unitRateINR":"263606.1","date":"14-Dec-2023","totalValueINR":"8171789","totalValueInUsd":"98167.7","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"1002281","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"ADD: HF 61,HAL FAR INDUSTRIAL ESTAT E,HAL FAR BBG3000 MALTA Malta","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723487400,"product":"SUNITINIB MALATE API","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"15","unit":"GMS","unitRateFc":"3.1","totalValueFC":"46.8","currency":"USD","unitRateINR":"261.6","date":"13-Aug-2024","totalValueINR":"3924.6","totalValueInUsd":"46.8","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"5034468","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"FTO -7, PLOT NO.P1 TO P9 V.S.E.Z., DUVVADA,VISAKHAPATNAM SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724956200,"product":"SUNITINIB MALATE API","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DR. REDDY\\'S LABORATORIES","supplierCountry":"INDIA","foreign_port":"VISAKHAPATNAM SEZ","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.001","unit":"KGS","unitRateFc":"3084","totalValueFC":"3.1","currency":"USD","unitRateINR":"261640","date":"30-Aug-2024","totalValueINR":"261.64","totalValueInUsd":"3.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"5324516","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VISAKHAPATNAM SEZ","supplierAddress":"FTO -7, PLOT NO.P1 TO P9 V.S.E.Z., DUVVADA, VISAKHAPATNAM SDNF India","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]
    08-Feb-2021
    17-Oct-2024
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    ABOUT THIS PAGE

    Looking for 341031-54-7 / Sunitinib API manufacturers, exporters & distributors?

    Sunitinib manufacturers, exporters & distributors 1

    55

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

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

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

    API | Excipient name

    Sunitinib

    Synonyms

    341031-54-7, Sutent, Su011248 l-malate salt, Sunitinib malate [usan], Pha-290940ad, Su010398

    Cas Number

    341031-54-7

    Unique Ingredient Identifier (UNII)

    LVX8N1UT73

    About Sunitinib

    An indole and pyrrole derivative that inhibits VEGFR-2 and PDGFR BETA RECEPTOR TYROSINE KINASES. It is used as an antineoplastic agent for the treatment of GASTROINTESTINAL STROMAL TUMORS, and for treatment of advanced or metastatic RENAL CELL CARCINOMA.

    Sunitinib Malate Manufacturers

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

    Sunitinib Malate Suppliers

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

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

    Sunitinib Malate USDMF

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

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

    click here to find a list of Sunitinib Malate suppliers with USDMF on PharmaCompass.

    Sunitinib Malate 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 Sunitinib Malate Drug Master File in Japan (Sunitinib Malate JDMF) empowers Sunitinib Malate 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 Sunitinib Malate JDMF during the approval evaluation for pharmaceutical products. At the time of Sunitinib Malate 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 Sunitinib Malate suppliers with JDMF on PharmaCompass.

    Sunitinib Malate KDMF

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

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

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

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

    Sunitinib Malate WC

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

    click here to find a list of Sunitinib Malate suppliers with Written Confirmation (WC) on PharmaCompass.

    Sunitinib Malate 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 Sunitinib Malate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Sunitinib Malate 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 Sunitinib Malate 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 Sunitinib Malate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sunitinib Malate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Sunitinib Malate suppliers with NDC on PharmaCompass.

    Sunitinib Malate GMP

    Sunitinib Malate 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 Sunitinib Malate 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 Sunitinib Malate GMP manufacturer or Sunitinib Malate GMP API supplier for your needs.

    Sunitinib Malate CoA

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

    Sunitinib Malate CoA mostly includes findings from lab analyses of a specific batch. For each Sunitinib Malate 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.

    Sunitinib Malate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sunitinib Malate EP), Sunitinib Malate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sunitinib Malate 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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