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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 12 USDMF, 1 JDMF, 9 EU WC, 6 KDMF, 7 NDC API, 35 Listed Suppliers, $ API Reference Price

43 API Suppliers
12 USDMF
1 JDMF
9 EU WC
6 KDMF
7 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

19 Drugs in Development

19 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

216 FDF Dossiers, 35 FDA Orange Book, 34 Europe, 15 Canada, 90 Australia, 3 South Africa, 39 Listed Dossiers

216 FDF Dossiers
35 FDA Orange Book
34 Europe
15 Canada
90 Australia
3 South Africa
39 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 7 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 1 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 2 Kerry, 3 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 6 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 Sigachi Industries, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

34 Fillers, Diluents & Binders, 15 Direct Compression, 13 Disintegrants & Superdisintegrants, 10 Chewable & Orodispersible Aids, 10 Granulation, 10 Taste Masking, 8 Thickeners and Stabilizers, 8 Lubricants & Glidants, 8 Empty Capsules, 8 Solubilizers, 7 Coating Systems & Additives, 7 Parenteral, 6 Co-Processed Excipients, 5 Film Formers & Plasticizers, 4 Controlled & Modified Release, 3 Coloring Agents, 3 Topical, 2 Emulsifying Agents, 1 Rheology Modifiers, 1 API Stability Enhancers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 61 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 25 Finished Drug Prices, 10 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
25 Finished Drug Prices
10 Annual Reports

MARKET PLACE

16 APIs, 10 FDF Dossiers

marketPlace
16 APIs
10 FDF Dossiers

PATENTS & EXCLUSIVITIES

16 Health Canada Patents

patents
16 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 Others

otherSolutions
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 5,833

MARKET PLACE

API

FDF

19INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

216

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

19DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

73,235,347

Annual Reports (USD Million)

7,352

Finished Drug Prices

94 RELATED EXCIPIENT COMPANIES

163EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₂₆H₃₃FN₄O₇
Molecular Weight	532.6 g/mol
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	10
Exact Mass	532.23332757 g/mol
Monoisotopic Mass	532.23332757 g/mol
Topological Polar Surface Area	172 Å²
Heavy Atom Count	38
Formal Charge	0
Complexity	765
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Sunitinib malate
Drug Label	SUTENT, 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 Ingredient	Sunitinib malate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base
Market Status	Prescription
Company	Mylan Pharms

2 of 2
Drug Name	Sunitinib malate
Drug Label	SUTENT, 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 Ingredient	Sunitinib malate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg base; eq 12.5mg base; eq 25mg base; eq 37.5mg base
Market Status	Prescription
Company	Mylan 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 SUPPLIERS

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USDMF

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JDMF

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EU WC

01

Cdymax

India

BIO Partnering at JPM

Not Confirmed

02

Hetero Drugs

India

BIO Partnering at JPM

Not Confirmed

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KDMF

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NDC API

01

Medichem S.A.

Spain

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

Spain

Virtual Booth

Digital Content

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

02

Medichem Manufacturing (Malta) Ltd.

Spain

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

Spain

Virtual Booth

Digital Content

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

03

Hetero Labs Limited

India

BIO Partnering at JPM

Not Confirmed

04

MSN Laboratories Private Limited

India

BIO Partnering at JPM

Not Confirmed

05

Pfizer Asia Manufacturing Pte Ltd

U.S.A

BIO Partnering at JPM

Not Confirmed

06

SHILPA PHARMA LIFESCIENCES LIMITED

India

BIO Partnering at JPM

Not Confirmed

07

Sicor S.r.l.

Italy

BIO Partnering at JPM

Not Confirmed

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Listed Suppliers

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API Reference Price

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DE C.V\/","customerCountry":"MEXICO","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"9281.9","totalValueFC":"125759.3","currency":"USD","unitRateINR":668761.78571428568,"date":"21-Apr-2021","totalValueINR":"9362665","totalValueInUsd":"125759.3","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"1254414","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MEXICO","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"HETERO HOUSE,H.NO.8-3-166\/7\/1ERRAGADDA, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"SUNITINIB","year":"2021","qtr":"Q2","strtotime":1619807400,"product":"SUNITINIB MALATE","address":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,","city":"RAICHUR , KARNATAKA","supplier":"SHILPA MEDICARE","supplierCountry":"INDIA","foreign_port":"MEXICO CITY","customer":"HELM 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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,,"}]

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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Drugs in Development

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INTERMEDIATES SUPPLIERS

01

Aventus Labs

India

China

BIO Partnering at JPM

Not Confirmed

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FDA Orange Book

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Europe

01

Helvepharm AG

France

BIO Partnering at JPM

Not Confirmed

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

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France

Virtual Booth

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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

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Product Web Link

02

Helvepharm AG

France

BIO Partnering at JPM

Not Confirmed

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

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France

Virtual Booth

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

Portfolio PDF

Product Web Link

03

Helvepharm AG

France

BIO Partnering at JPM

Not Confirmed

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

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France

Virtual Booth

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

Portfolio PDF

Product Web Link

04

Adamed Sp. z.o.o.

Poland

BIO Partnering at JPM

Not Confirmed

05

AqVida GmbH

Germany

BIO Partnering at JPM

Not Confirmed

06

BLUEPHARMA - INDUSTRIA FARMACEUTICA, S.A

Portugal

Israel

BIO Partnering at JPM

Not Confirmed

10

Viatris Pharma GmbH

U.S.A

BIO Partnering at JPM

Not Confirmed

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Canada

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Australia

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South Africa

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Listed Dossiers

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Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

Direct Compression

Disintegrants & Superdisintegrants

Chewable & Orodispersible Aids

Granulation

Taste Masking

Thickeners and Stabilizers

Lubricants & Glidants

Empty Capsules

Solubilizers

Coating Systems & Additives

Parenteral

Co-Processed Excipients

Film Formers & Plasticizers

Controlled & Modified Release

Coloring Agents

Topical

Emulsifying Agents

Rheology Modifiers

API Stability Enhancers

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Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

01

Brand Name : Sunitinib Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

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France

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RX/OTC/DISCN : Class A

Helvepharm AG

Sunitinib

Dosage Form : Kaps

Dosage Strength : 12.5mg

Price Per Pack (Euro) : 800.81

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Product Web Link

02

Brand Name : Sunitinib Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

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France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class A

Helvepharm AG

Sunitinib

Dosage Form : Caps

Dosage Strength : 50mg

Price Per Pack (Euro) : 3046.34

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Portfolio PDF

Product Web Link

03

Brand Name : Sunitinib Zentiva

France

BIO Partnering at JPM

Not Confirmed

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

Contact Supplier

France

Virtual Booth

Digital Content

RX/OTC/DISCN : Class A

Helvepharm AG

Sunitinib

Dosage Form : Kaps

Dosage Strength : 25mg

Price Per Pack (Euro) : 1601.5

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

Portfolio PDF

Product Web Link

Virtual Booth

U.S.A

BIO Partnering at JPM

Not Confirmed

Sunitinib Malate

BIO Partnering at JPM

Not Confirmed

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Market Place

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APIs

IP/USP Grade Sunitinib (22 kg) API needed in India [ENA19188]

A CDMO that focuses on the development, manufacturing & marketing of niche finished formulations is looking for suppliers of IP/USP Grade Sunitinib (22 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

13 Mar 2024

Sunitinib Malate (5 kg) API needed in Iran [ENA17435]

A company that deals in various pharmaceutical products is looking for suppliers of Sunitinib Malate (5 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

30 Jun 2023

Sunitinib Malate (500 g) API needed in India [ENA17203]

A company that deals in various pharmaceutical products is looking for suppliers of Sunitinib Malate (500 g) API for commercial purposes. The suppliers must support this enquiry with CoA.

31 May 2023

Sunitinib (100 g & 1 kg) API needed in Russia [ENA13140]

A leading Russian pharmaceutical company that specializes in synthesis of innovative substances and modern dosage forms is looking for suppliers of Sunitinib (100 g & 1 kg) API for development purpose. The suppliers must support this enquiry with CoA.

29 Mar 2022

Various APIs needed in India [ENA12450]

A company based in Japan that deals in research, development & manufacturing of pharmaceutical products for human & animal use is looking for suppliers of Various APIs for commercial purpose. The required quantity is 100 kg for each. The suppliers must support this enquiry with CoA. 1. Sugammadex Sodium API 2. Amenamevir API 3. Relugolix API 4. Sunitinib API 5. Lacosamide API 6. Bosunitinib API 7. Teneligliptin API

19 Jan 2022

Sunitinib (MOQ) API needed in Bangladesh [ENA11122]

Pharma Point, a company that deals in the distribution of various pharmaceutical products is looking for suppliers of Sunitinib (MOQ) API for commercial purpose. The suppliers must support this enquiry with CoA. Interested suppliers can contact them via their email: spharmapoint@gmail.com.

16 Aug 2021

Sunitinib Malate (100 g) API needed in India [ENA10628]

A company that focuses on injectables, ophthalmics, semi-solid, and liquid oral-based products is looking for suppliers of Sunitinib Malate (100 g) API for development purposes. The suppliers must support this enquiry with DMF and CoA.

14 Jun 2021

Various APIs needed in Saudi Arabia [ENA09977]

Kinda Chemicals, a company that deals in pharmaceutical products is looking for suppliers of Various APIs for development purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with GMP and DMF. Interested suppliers can contact them via their email: sales@kindachemicals.com. 1. Sorafenib Tosylate API 2. Palbociclib API 3. Osimertinib Mesylate API 4. Sunitinib Malate API 5. Gilteritinib Fumarate API

18 Mar 2021

Various APIs needed in Russia [ENA09584]

A top Russian pharmaceutical company that is a leader in the spheres of the synthesis of innovative substances and modern dosage forms is looking for suppliers of Various APIs for development purposes. The suppliers must support this enquiry with CoA. 1. Pazopanib HCl (5 kg - 6 kg) API 2. Sorafenib Tosylate (3 kg - 4 kg) API 3. Sunitinib Malate (3 kg) API 4. Pomalidomide (1 kg) API 5. Dasatinib Monohydrate (3 kg - 4 kg) API 6. Gefitinib (5 kg - 6 kg) API 7. Cabazitaxel (1 kg - 2 kg) API

27 Jan 2021

Various APIs needed in India [ENA08724]

A pharmaceutical company that deals in the manufacturing of tablets, capsules & powder sachets is looking for suppliers of Various APIs. The suppliers must support this enquiry with CoA. 1. Miraculin (CAS 198694-37-0) API. The required quantity is 50 g for research purposes. 2. Sunitinib Malate (MOQ) API. 3. Dapagliflozin (100 g) API.

05 Oct 2020

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

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Health Canada Patents

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ABOUT THIS PAGE

Sunitinib Manufacturers

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

Sunitinib Suppliers

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

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

Sunitinib USDMF

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

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

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

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

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

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

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

Sunitinib WC

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

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

Sunitinib 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sunitinib GMP

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

Sunitinib CoA

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

Sunitinib CoA mostly includes findings from lab analyses of a specific batch. For each Sunitinib 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Sunitinib EP), Sunitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sunitinib 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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