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Synopsis

Chemistry

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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


EU WC

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Cdymax

India
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Cdymax

India
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Sunitinib Malate

Date of Issue : 2024-11-28

Valid Till : 2024-07-15

Written Confirmation Number : WC-0327n

Address of the Firm : Plot No 116/117, KIADB Industrial Area, Jigani, Bangalore,Karnataka, India

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Hetero Drugs

India
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Hetero Drugs

India
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Sunitinib Malate IH

Date of Issue : 2022-09-16

Valid Till : 2025-08-08

Written Confirmation Number : WC-0041

Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...

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Laurus Labs

India
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Laurus Labs

India
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Sunitinib IH

Date of Issue : 2023-07-03

Valid Till : 2025-07-02

Written Confirmation Number : WC-0213

Address of the Firm : Plot No.21, Jawaharlal Nehru Pharma City, Parawada MandaI, Visakhapatnam, Visakh...

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Sunitinib Malate IH

Date of Issue : 2022-09-02

Valid Till : 2025-05-05

Written Confirmation Number : WC-0349

Address of the Firm : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...

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Sunitinib Malate IH

Date of Issue : 2020-02-10

Valid Till : 2022-05-05

Written Confirmation Number : WC-0349A8

Address of the Firm : Unit-||, Sy. No. 50, Kardanur Village, Patti/Post Patancheru Mandal,Sangareddy D...

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Sunitinib Malate IH

Date of Issue : 2022-08-31

Valid Till : 2025-07-21

Written Confirmation Number : WC-0198

Address of the Firm : R-282, Plant-3, TTC Area of MIDC, Thane- Belapur Road, Rabale, Navi Mumbai-400 7...

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Sunitinib Malate IH

Date of Issue : 2021-06-11

Valid Till : 2022-07-02

Written Confirmation Number : WC-0147A3

Address of the Firm : 100% EOU, Raichur Industrial Growth Centre, Plot No. 33, 33A, 40-47, Chicksugur-...

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Sunitinib Malate IH

Date of Issue : 2021-01-08

Valid Till : 2022-07-25

Written Confirmation Number : WC-0159A3

Address of the Firm : A-7/A-8 MIDC, Industrial Area, Ahmednagar,414111,Maharastra,India

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Viatris

U.S.A
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Viatris

U.S.A
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Sunitinib Malate (INH)

Date of Issue : 2019-10-11

Valid Till : 2022-07-02

Written Confirmation Number : WC-0157

Address of the Firm : Plot No. 1A/2, MIDC, Taloja, Panvel, Dist. Raigad, Maharashtra State

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NDC API

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Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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SUNITINIB MALATE

NDC Package Code : 53296-0091

Start Marketing Date : 2010-06-02

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (75kg/75kg)

Marketing Category : BULK INGREDIENT

Medichem

02

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  • fda
  • EDQM
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Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

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SUNITINIB MALATE

NDC Package Code : 16436-0091

Start Marketing Date : 2010-06-04

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (75kg/75kg)

Marketing Category : BULK INGREDIENT

Medichem

03

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SUNITINIB MALATE

NDC Package Code : 68554-0078

Start Marketing Date : 2006-01-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUNITINIB MALATE

NDC Package Code : 54893-0081

Start Marketing Date : 2018-11-28

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUNITINIB MALATE

NDC Package Code : 68724-1234

Start Marketing Date : 2019-07-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUNITINIB MALATE

NDC Package Code : 82920-037

Start Marketing Date : 2023-09-27

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Sicor S.r.l.

Italy
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Sicor S.r.l.

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SUNITINIB MALATE

NDC Package Code : 53183-4012

Start Marketing Date : 2018-03-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (100kg/100kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"3211.1","totalValueFC":"38415.5","currency":"USD","unitRateINR":"247414","date":"17-May-2022","totalValueINR":"2968968","totalValueInUsd":"38415.5","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"1000713","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":"2022","qtr":"Q2","strtotime":1655317800,"product":"(RE-IMPORT-REJECTED CARGO)SUNITINIB(BATCH NO;SNTA21003)","address":"N0 116\/117, KIADB INDUSTRIAL AREA, ,JIGANI 2ND PHASE","city":"BANGALORE,KARNATAKA","supplier":"PHARMACARE PREMIUM","supplierCountry":"MALTA","foreign_port":"NA","customer":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2.93","actualQuantity":"2.925","unit":"KGS","unitRateFc":"3500","totalValueFC":"10509","currency":"USD","unitRateINR":"280294.1","date":"16-Jun-2022","totalValueINR":"819860.25","totalValueInUsd":"10509","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":"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":"Q2","strtotime":1681065000,"product":"SUNITINIB MALATE (REJECTED GOODS VIDE SB NO-4634383\/06-10-22; EXP INV-NO-SI3622224994 DT-29-9-22)","address":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta","city":"HYDERABAD","supplier":"LOTUS PHARMACEUTICAL","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"59.60","actualQuantity":"59.596","unit":"KGS","unitRateFc":"6000","totalValueFC":"366896.7","currency":"USD","unitRateINR":"504540","date":"10-Apr-2023","totalValueINR":"30068568.2","totalValueInUsd":"366896.7","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"5441119","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"HETERO CORPORATE, NO. 7-2-A2, INDUSTRIAL ESTATE,SANATHNAGAR Conta"},{"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":"Q2","strtotime":1713983400,"product":"SUNITINIB MALATE API","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":"26.00","actualQuantity":"26","unit":"KGS","unitRateFc":"3129.8","totalValueFC":"82244.9","currency":"USD","unitRateINR":"264155.8","date":"25-Apr-2024","totalValueINR":"6868050","totalValueInUsd":"82244.9","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"1000783","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"HF 61,HAL FAR INDUSTRIAL ESTATE HAL FAR BBG 3000 MALTA , MALTA MALTA","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1727980200,"product":"SUNITINIB","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":"0.00","actualQuantity":"0.05","unit":"GMS","unitRateFc":"4714.2","totalValueFC":"238","currency":"USD","unitRateINR":"400000","date":"04-Oct-2024","totalValueINR":"20000","totalValueInUsd":"238","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29339990","bill_no":"5953261","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":"Q4","strtotime":1732645800,"product":"SUNITINIB MALATE","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"MALTA (VALETTA)","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"3100","totalValueFC":"62706.6","currency":"USD","unitRateINR":"264585","date":"27-Nov-2024","totalValueINR":"5291700","totalValueInUsd":"62706.6","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29337990","bill_no":"6904017","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALETTA)","supplierAddress":"HF 61,Hal Far Industrial Estatae Hal Far BBG3000 SDNF Malta","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]
09-Feb-2021
27-Nov-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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INTERMEDIATES SUPPLIERS

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01

Aventus Labs

India
BIO Partnering at JPM
Not Confirmed
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Aventus Labs

India
BIO Partnering at JPM
Not Confirmed
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CAS Number : 56341-41-4

End Use API : Sunitinib

About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...

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02

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed
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CAS Number : 356068-86-5

End Use API : Sunitinib

About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...

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03

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed
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CAS Number : 253870-02-9

End Use API : Sunitinib

About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...

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04

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed
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CAS Number : 2199-59-9

End Use API : Sunitinib

About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...

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05

BIO Partnering at JPM
Not Confirmed
arrow
BIO Partnering at JPM
Not Confirmed
arrow

CAS Number : 2199-51-1

End Use API : Sunitinib

About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...

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06

BIO Partnering at JPM
Not Confirmed
arrow
BIO Partnering at JPM
Not Confirmed
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CAS Number : 56341-41-4

End Use API : Sunitinib

About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...

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07

BIO Partnering at JPM
Not Confirmed
arrow
BIO Partnering at JPM
Not Confirmed
arrow

CAS Number : 356068-86-5

End Use API : Sunitinib

About The Company : Chengda Pharmaceutical Co., Ltd. was founded in 1999. It is located in the Hangzhou-Jiaxing-Huzhou plain, Jiashan Economic & Technological Development Zone (nat...

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08

BIO Partnering at JPM
Not Confirmed
arrow
BIO Partnering at JPM
Not Confirmed
arrow

CAS Number : 56341-41-4

End Use API : Sunitinib

About The Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 ye...

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09

BIO Partnering at JPM
Not Confirmed
arrow
BIO Partnering at JPM
Not Confirmed
arrow

CAS Number : 356068-86-5

End Use API : Sunitinib

About The Company : Fujian South Pharmaceutical Co., Ltd. (Southern Pharmaceutical) was established in September 2001 and is located in Mingxi County, Fujian Province. After 16 ye...

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10

BIO Partnering at JPM
Not Confirmed
arrow
BIO Partnering at JPM
Not Confirmed
arrow

CAS Number : 356068-86-5

End Use API : Sunitinib

About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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Europe

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01

Helvepharm AG

France
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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Sunitinibum

Brand Name : Sunitinib Zentiva

Dosage Form : Kaps

Dosage Strength : 12.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

Helvepharm AG

France
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Sunitinibum

Brand Name : Sunitinib Zentiva

Dosage Form : Kaps

Dosage Strength : 25mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

Helvepharm AG

France
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Sunitinibum

Brand Name : Sunitinib Zentiva

Dosage Form : Caps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

04

BIO Partnering at JPM
Not Confirmed
arrow
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BIO Partnering at JPM
Not Confirmed

Sunitinib

Brand Name :

Dosage Form :

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Poland

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05

AqVida GmbH

Germany
BIO Partnering at JPM
Not Confirmed
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AqVida GmbH

Germany
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 50MG

Packaging : Capsule (Box/Bottle)

Approval Date :

Application Number :

Regulatory Info : Generic Submission Scheduled

Registration Country : Germany

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06

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SUNITINIB MALATE

Brand Name :

Dosage Form : Capsule

Dosage Strength : 37.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

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07

Pfizer Ltd.

U.S.A
BIO Partnering at JPM
Not Confirmed
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Pfizer Ltd.

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

sunitinib malate

Brand Name : SUTENT

Dosage Form : HARD CAPSULES

Dosage Strength : 37.5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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08

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Brand Name : Sutent

Dosage Form : Capsule, hard

Dosage Strength : 25 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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09

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinibum

Brand Name : Sunitinib-Teva

Dosage Form : Kaps

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinibum

Brand Name : Sunitinib Mylan

Dosage Form : Caps

Dosage Strength : 12.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Disintegrants & Superdisintegrants

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Chewable & Orodispersible Aids

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Granulation

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Taste Masking

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Thickeners and Stabilizers

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Lubricants & Glidants

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Empty Capsules

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Solubilizers

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Film Formers & Plasticizers

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Coloring Agents

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Finished Drug Prices

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01

Brand Name : Sunitinib Zentiva

France
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RX/OTC/DISCN : Class A

Sunitinib

Dosage Form : Kaps

Dosage Strength : 12.5mg

Price Per Pack (Euro) : 800.81

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Sanofi Company Banner

02

Brand Name : Sunitinib Zentiva

France
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RX/OTC/DISCN : Class A

Sunitinib

Dosage Form : Caps

Dosage Strength : 50mg

Price Per Pack (Euro) : 3046.34

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Sanofi Company Banner

03

Brand Name : Sunitinib Zentiva

France
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

RX/OTC/DISCN : Class A

Sunitinib

Dosage Form : Kaps

Dosage Strength : 25mg

Price Per Pack (Euro) : 1601.5

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Sanofi Company Banner

04

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Caps

Dosage Strength : 12.5mg

Price Per Pack (Euro) : 889.78

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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05

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Caps

Dosage Strength : 25mg

Price Per Pack (Euro) : 1779.44

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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06

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Caps

Dosage Strength : 50mg

Price Per Pack (Euro) : 3384.8

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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07

Brand Name : Sunitinib Mylan

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sunitinib Mylan

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Caps

Dosage Strength : 12.5mg

Price Per Pack (Euro) : 800.81

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

blank

08

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Capsule, hard

Dosage Strength : 12.5 mg

Price Per Pack (Euro) : 1,513.02

Published in :

Country : Norway

RX/OTC/DISCN :

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09

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Capsule, hard

Dosage Strength : 25 mg

Price Per Pack (Euro) : 3,021.22

Published in :

Country : Norway

RX/OTC/DISCN :

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10

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib

Dosage Form : Capsule, hard

Dosage Strength : 50 mg

Price Per Pack (Euro) : 6,037.42

Published in :

Country : Norway

RX/OTC/DISCN :

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Annual Reports

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01

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2019 Revenue in Millions : 936

2018 Revenue in Millions : 1,049

Growth (%) : -11

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02

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2020 Revenue in Millions : 819

2019 Revenue in Millions : 936

Growth (%) : -13

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03

Brand Name : Sutent

Sunitinib Malate

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BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
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BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2021 Revenue in Millions : 673

2020 Revenue in Millions : 819

Growth (%) : -18

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04

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2022 Revenue in Millions : 347

2021 Revenue in Millions : 673

Growth (%) : -48

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05

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 180

2022 Revenue in Millions : 347

Growth (%) : -48

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06

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2014 Revenue in Millions : -2.40%

2013 Revenue in Millions :

Growth (%) :

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07

Brand Name : Sutent

Sunitinib Malate

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BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2015 Revenue in Millions : 1,174

2014 Revenue in Millions : 1,120

Growth (%) : -5%

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08

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2016 Revenue in Millions : 1,095

2015 Revenue in Millions : 1,120

Growth (%) : -2

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09

Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2017 Revenue in Millions : 1,081

2016 Revenue in Millions : 1,096

Growth (%) : -1

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Brand Name : Sutent

Sunitinib Malate

arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Sunitinib Malate

Main Therapeutic Indication : Oncology

Currency : USD

2018 Revenue in Millions : 1,049

2017 Revenue in Millions : 1,081

Growth (%) : -3%

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ABOUT THIS PAGE

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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