All Manufacturers, Suppliers, Distributors and Exporters of Sunitinib Malate with approved Medicines Control Council in South Africa of Finished Dosage Form listed on PharmaCompass.com

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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


NDC API

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01

  • 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 : 2024-12-31

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

Marketing Category : BULK INGREDIENT

Medichem

02

  • fda
  • EDQM
  • WHO-GMP

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 : 2024-12-31

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

Marketing Category : BULK INGREDIENT

Medichem

03

Discovery on Target
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SUNITINIB MALATE

NDC Package Code : 68554-0078

Start Marketing Date : 2006-01-26

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 : 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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05

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SUNITINIB MALATE

NDC Package Code : 68724-1234

Start Marketing Date : 2019-07-01

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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06

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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.

Italy
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SUNITINIB MALATE

NDC Package Code : 53183-4012

Start Marketing Date : 2018-03-26

End Marketing Date : 2024-12-31

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

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Sunitinib

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Sunitinib Malate

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Sunitinib

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Sunitinib

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing and supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Medichem S.A

Spain
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About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...

Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceutical Ingredients (APIs), including Highly Potent. In 2016, Medichem merged with Combino Pharm, which is devoted to the development and manufacture (licensing) of Finished Dosage Forms. With this merger, Medichem has become a vertically integrated pharmaceutical company which can offer a complete range of products and services for the pharmaceutical industry with the highest standards of quality, operational excellence and environment respect.
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Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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Sunitinib

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.
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Virtual BoothTofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.

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Sunitinib

About the Company : Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like A...

Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like Anti-cancer, Anti-diabetics, Cardiovascular & Narcotics. Today, we boast to be the one & only producer of specialized APIs like Glatiramer, Fentanyl, Remifentanil, Atracurium, and peptides including long-acting Triptorelin and we have 5 PIC/s GMP-approved production lines. We also produce semi-finished products, granules for hazardous substances & FDF know-how, tech transfers & CTD compilations. We are exporting our products to Turkey, Bulgaria, Russia, & Algeria.
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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 chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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SUNITINIB MALATE

About the Company : Specialità Fine Chemicals was established in 2013, through an initiative of Prati-Donaduzzi Group, aiming at the development of the manufacturing process of Active Pharmaceutical ...

Specialità Fine Chemicals was established in 2013, through an initiative of Prati-Donaduzzi Group, aiming at the development of the manufacturing process of Active Pharmaceutical Ingredients (APIs) considered strategic for the company's business. We started the work focused on some generic anticancer drug substances. For the development of the manufacturing processes of these products, a state-of-the-art organic synthesis laboratory with a total of 250 square-meters built-up area has been structured and equipped in order to allow the synthesis of organic compounds from the scale of units of grams up to the scale of hundreds of grams.
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Synthland

China
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Synthland

China
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Sunitinib

About the Company : Synthland is an integrated pharmaceutical company that develops, produce and supplies Active Pharmaceutical Ingredients (APIs) and Intermediates. We also represent some well-known...

Synthland is an integrated pharmaceutical company that develops, produce and supplies Active Pharmaceutical Ingredients (APIs) and Intermediates. We also represent some well-known GMP factories in China for their sales and business development to global market. Most of the products have USDMF, EDMF, CEP, etc, and we have a professional regulatory affairs team who will provide you the documentation as per relative authority's requirement and accelerate your drug application process. Our product category includes Oncology, Anti-infective, Anti-diabetic, Prostaglandin, Immunosuppressant and Veterinary, etc.
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API Reference Price

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25-Jan-2021
13-Aug-2024
KGS
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Average Price (USD/KGS)

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Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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Drugs in Development

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Details:

CGT9486 (bezuclastinib), is a KIT mutant inhibitor, being investigated in combination with sunitinib for patients living with gastrointestinal stromal tumors.


Lead Product(s): Bezuclastinib,Sunitinib

Therapeutic Area: Oncology Brand Name: CGT9486

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 03, 2024

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01

Discovery on Target
Not Confirmed
Discovery on Target
Not Confirmed

Details : CGT9486 (bezuclastinib), is a KIT mutant inhibitor, being investigated in combination with sunitinib for patients living with gastrointestinal stromal tumors.

Brand Name : CGT9486

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 03, 2024

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Details:

The net proceeds will be used for the clinical development of CGT9486 (bezuclastinib), which is a KIT mutant inhibitor for patients living with systemic mastocytosis and gastrointestinal stromal tumors.


Lead Product(s): Bezuclastinib,Sunitinib

Therapeutic Area: Oncology Brand Name: CGT9486

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: J.P. Morgan

Deal Size: $225.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement February 14, 2024

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02

Discovery on Target
Not Confirmed
Discovery on Target
Not Confirmed

Details : The net proceeds will be used for the clinical development of CGT9486 (bezuclastinib), which is a KIT mutant inhibitor for patients living with systemic mastocytosis and gastrointestinal stromal tumors.

Brand Name : CGT9486

Molecule Type : Small molecule

Upfront Cash : Undisclosed

February 14, 2024

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Details:

Cogent intends to fund the development, regulatory and commercial preparation activities relating to CGT9486 (bezuclastinib), a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17.


Lead Product(s): Bezuclastinib,Sunitinib

Therapeutic Area: Oncology Brand Name: CGT9486

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: J.P. Morgan

Deal Size: $150.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 06, 2023

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03

Discovery on Target
Not Confirmed
Discovery on Target
Not Confirmed

Details : Cogent intends to fund the development, regulatory and commercial preparation activities relating to CGT9486 (bezuclastinib), a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in ...

Brand Name : CGT9486

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 06, 2023

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Details:

Cabometyx (cabozantinib) is a multiple receptor tyrosine kinases inhibitor. These receptors are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, maintenance of the tumor microenvironment, etc.


Lead Product(s): Cabozantinib,Nivolumab,Sunitinib

Therapeutic Area: Oncology Brand Name: Cabometyx

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 13, 2023

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04

Ipsen

France
arrow
Discovery on Target
Not Confirmed

Ipsen

France
arrow
Discovery on Target
Not Confirmed

Details : Cabometyx (cabozantinib) is a multiple receptor tyrosine kinases inhibitor. These receptors are involved in both normal cellular function and pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, maintenance of the tumor microenvironm...

Brand Name : Cabometyx

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 13, 2023

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Details:

The net proceeds from the offering will be used for development, regulatory and commercial preparation activities relating to CGT9486 (bezuclastinib) and other product candidates, as well as for working capital and general corporate purposes.


Lead Product(s): Bezuclastinib,Sunitinib

Therapeutic Area: Oncology Brand Name: CGT9486

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Jefferies

Deal Size: $172.6 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 16, 2022

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05

Discovery on Target
Not Confirmed
Discovery on Target
Not Confirmed

Details : The net proceeds from the offering will be used for development, regulatory and commercial preparation activities relating to CGT9486 (bezuclastinib) and other product candidates, as well as for working capital and general corporate purposes.

Brand Name : CGT9486

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 16, 2022

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Details:

Cogent intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to CGT9486 (bezuclastinib) and other product candidates, as well as for working capital and general corporate purposes.


Lead Product(s): Bezuclastinib,Sunitinib

Therapeutic Area: Oncology Brand Name: CGT9486

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Jefferies

Deal Size: $150.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering June 14, 2022

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06

Discovery on Target
Not Confirmed
Discovery on Target
Not Confirmed

Details : Cogent intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to CGT9486 (bezuclastinib) and other product candidates, as well as for working capital and general corporate purposes.

Brand Name : CGT9486

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 14, 2022

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Details:

Updated outcomes from trial evaluating combination of Cabometyx (Cabozantinib) plus atezolizumab in an expanded patient population in NSCLC demonstrate encouraging clinical activity with manageable toxicity in people previously treated with an immune checkpoint inhibitor.


Lead Product(s): Cabozantinib,Nivolumab,Sunitinib

Therapeutic Area: Oncology Brand Name: Cabometyx

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2022

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07

Ipsen

France
arrow
Discovery on Target
Not Confirmed

Ipsen

France
arrow
Discovery on Target
Not Confirmed

Details : Updated outcomes from trial evaluating combination of Cabometyx (Cabozantinib) plus atezolizumab in an expanded patient population in NSCLC demonstrate encouraging clinical activity with manageable toxicity in people previously treated with an immune che...

Brand Name : Cabometyx

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 26, 2022

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Details:

GB-102 is a microparticle formulation of a pan-VEGF inhibitor, sunitinib, for the treatment of wet age-related macular degeneration designed for a twice-per-year intravitreal injection. GB-102 has the potential to also benefit patients with diabetic retinopathy.


Lead Product(s): Sunitinib

Therapeutic Area: Ophthalmology Brand Name: GB-102

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 19, 2022

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08

CalciMedica

U.S.A
arrow
Discovery on Target
Not Confirmed

CalciMedica

U.S.A
arrow
Discovery on Target
Not Confirmed

Details : GB-102 is a microparticle formulation of a pan-VEGF inhibitor, sunitinib, for the treatment of wet age-related macular degeneration designed for a twice-per-year intravitreal injection. GB-102 has the potential to also benefit patients with diabetic reti...

Brand Name : GB-102

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 19, 2022

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Details:

The MERECA study showed that the combination of ilixadencel with the tyrosine kinase inhibitor sunitinib was safe and associated with a positive trend for improved tumor response rate and overall survival, compared with sunitinib monotherapy (control group).


Lead Product(s): Ilixadencel,Sunitinib

Therapeutic Area: Oncology Brand Name: Intuvax

Study Phase: Phase IIProduct Type: Cell and Gene therapy

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2022

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09

Mendus

Sweden
arrow
Discovery on Target
Not Confirmed

Mendus

Sweden
arrow
Discovery on Target
Not Confirmed

Lead Product(s) : Ilixadencel,Sunitinib

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : The MERECA study showed that the combination of ilixadencel with the tyrosine kinase inhibitor sunitinib was safe and associated with a positive trend for improved tumor response rate and overall survival, compared with sunitinib monotherapy (control gro...

Brand Name : Intuvax

Molecule Type : Cell and Gene therapy

Upfront Cash : Not Applicable

April 28, 2022

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Details:

Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).


Lead Product(s): Bezuclastinib,Sunitinib

Therapeutic Area: Oncology Brand Name: CGT9486

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 08, 2022

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10

Discovery on Target
Not Confirmed
Discovery on Target
Not Confirmed

Details : Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Brand Name : CGT9486

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 08, 2022

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FDF Dossiers

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01

Sanofi

France
  • 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

Sanofi

France
  • 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

Sanofi

France
  • 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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

SUNITINIB MALATE

Brand Name : SUNITINIB MALATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 12.5MG BASE

Packaging :

Approval Date : 2022-04-11

Application Number : 215843

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

SUNITINIB MALATE

Brand Name : SUNITINIB MALATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 25MG BASE

Packaging :

Approval Date : 2022-04-11

Application Number : 215843

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : RX

Registration Country : USA

SUNITINIB MALATE

Brand Name : SUNITINIB MALATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 37.5MG BASE

Packaging :

Approval Date : 2022-04-11

Application Number : 215843

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Sunitinib

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 12.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Sunitinib

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Sunitinib

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 37.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Flag India
Digital Content Digital Content

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Sunitinib

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner
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US Medicaid Prescriptions

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01

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 55,637,386

Year : 2022

Prescribers : 1179

Prescriptions : 6128

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02

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 17,597,961

Year : 2022

Prescribers : 339

Prescriptions : 1442

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03

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 15,553,046

Year : 2021

Prescribers : 644

Prescriptions : 1600

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04

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 96,954,410

Year : 2021

Prescribers : 1515

Prescriptions : 7602

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05

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 120,222,574

Year : 2020

Prescribers : 1887

Prescriptions : 9953

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06

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 160,489,804

Year : 2019

Prescribers : 2595

Prescriptions : 13790

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07

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 193,354,311

Year : 2018

Prescribers : 3371

Prescriptions : 17143

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08

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 174,929,778

Year : 2017

Prescribers : 3428

Prescriptions : 16340

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09

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 183,064,145

Year : 2016

Prescribers : 3883

Prescriptions : 18549

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10

arrow
ASC 2024
Not Confirmed
arrow
ASC 2024
Not Confirmed

Company :

Sunitinib Malate

Drug Cost (USD) : 160,910,812

Year : 2015

Prescribers : 3982

Prescriptions : 16992

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Finished Drug Prices

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01

Brand Name : Sunitinib Zentiva

France
  • 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
  • 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
  • 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
ASC 2024
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
ASC 2024
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

blank

05

Brand Name : Sutent

U.S.A
arrow
ASC 2024
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
ASC 2024
Not Confirmed

Sunitinib

Dosage Form : Caps

Dosage Strength : 25mg

Price Per Pack (Euro) : 1779.44

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

blank

06

Brand Name : Sutent

U.S.A
arrow
ASC 2024
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
ASC 2024
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
ASC 2024
Not Confirmed

Brand Name : Sunitinib Mylan

U.S.A
arrow
ASC 2024
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
ASC 2024
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
ASC 2024
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
ASC 2024
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
ASC 2024
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
ASC 2024
Not Confirmed

Brand Name : Sutent

U.S.A
arrow
ASC 2024
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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