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Chemistry

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Also known as: 319460-85-0, Ag-013736, Inlyta, Ag 013736, (e)-n-methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-yl)thio)benzamide, Ag-13736
Molecular Formula
C22H18N4OS
Molecular Weight
386.5  g/mol
InChI Key
RITAVMQDGBJQJZ-FMIVXFBMSA-N
FDA UNII
C9LVQ0YUXG

Axitinib
A benzamide and indazole derivative that acts as a TYROSINE KINASE inhibitor of the VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR. It is used in the treatment of advanced RENAL CELL CARCINOMA.
Axitinib is a Kinase Inhibitor. The mechanism of action of axitinib is as a Receptor Tyrosine Kinase Inhibitor.
1 2D Structure

Axitinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide
2.1.2 InChI
InChI=1S/C22H18N4OS/c1-23-22(27)18-7-2-3-8-21(18)28-16-10-11-17-19(25-26-20(17)14-16)12-9-15-6-4-5-13-24-15/h2-14H,1H3,(H,23,27)(H,25,26)/b12-9+
2.1.3 InChI Key
RITAVMQDGBJQJZ-FMIVXFBMSA-N
2.1.4 Canonical SMILES
CNC(=O)C1=CC=CC=C1SC2=CC3=C(C=C2)C(=NN3)C=CC4=CC=CC=N4
2.1.5 Isomeric SMILES
CNC(=O)C1=CC=CC=C1SC2=CC3=C(C=C2)C(=NN3)/C=C/C4=CC=CC=N4
2.2 Other Identifiers
2.2.1 UNII
C9LVQ0YUXG
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ag 013736

2. Ag-013736

3. Ag013736

4. Inlyta

2.3.2 Depositor-Supplied Synonyms

1. 319460-85-0

2. Ag-013736

3. Inlyta

4. Ag 013736

5. (e)-n-methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-yl)thio)benzamide

6. Ag-13736

7. Ag013736

8. C9lvq0yuxg

9. N-methyl-2-((3-((1e)-2-(pyridin-2-yl)ethenyl)-1h-indazol-6-yl)sulfanyl)benzamide

10. Nsc-757441

11. Chebi:66910

12. (e)-n-methyl-2-(3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-ylthio)benzamide

13. N-methyl-2-[[3-[(e)-2-pyridin-2-ylethenyl]-1h-indazol-6-yl]sulfanyl]benzamide

14. Nsc757441

15. N-methyl-2-({3-[(e)-2-(pyridin-2-yl)ethenyl]-1h-indazol-6-yl}sulfanyl)benzamide

16. Ncgc00241108-01

17. S1005

18. Dsstox_cid_28975

19. Dsstox_rid_83240

20. Dsstox_gsid_49049

21. Axitinib (ag 013736)

22. N-methyl-2-({3-[(e)-2-(pyridin-2-yl)vinyl]-1h-indazol-6-yl}sulfanyl)benzamide

23. N-methyl-2-(3-((e)-2-pyridin-2-yl-vinyl)-1h-indazol-6-ylsulfanyl)-benzamide

24. Axitinib [usan]

25. Cas-319460-85-0

26. Unii-c9lvq0yuxg

27. Axitinibum

28. Axitinib [usan:inn:jan]

29. 4agc

30. Benzamide, N-methyl-2-((3-((1e)-2-(2-pyridinyl)ethenyl)-1h-indazol-6-yl)thio)-

31. Benzamide, N-methyl-2-[[3-[(1e)-2-(2-pyridinyl)ethenyl]-1h-indazol-6-yl]thio]-

32. Inlyta (tn)

33. Mfcd09837898

34. Ag13736

35. 4ag8

36. Axitinib (jan/usan)

37. Axitinib [inn]

38. Axitinib [jan]

39. Axitinib [mi]

40. Axitinib [vandf]

41. Axitinib [mart.]

42. Ag-013736;axitinib

43. Axitinib [who-dd]

44. Axitinib,ag-013736

45. Mls006010164

46. Schembl172918

47. Axitinib [orange Book]

48. Gtpl5659

49. Axitinib, >=98% (hplc)

50. Chembl1289926

51. Dtxsid3049049

52. N-methyl-2-[[3-[2-(2-pyridinyl)ethenyl]-1h-indazol-6-yl]thio]benzamide

53. Schembl22930506

54. Bdbm25117

55. Chebi:94568

56. Ex-a337

57. Bcpp000372

58. Bcp01371

59. Zinc3816287

60. Tox21_113597

61. Nsc799341

62. Akos015902898

63. Tox21_113597_1

64. Ac-1539

65. Bcp9000345

66. Ccg-264772

67. Cs-0116

68. Db06626

69. Ks-1448

70. Nsc 757441

71. Nsc-799341

72. Benzamide, N-methyl-2-((3-((e)-2-(2-pyridinyl)ethenyl)-1h-indazol-6-yl)thio)-

73. Ncgc00241108-04

74. Ncgc00241108-06

75. Hy-10065

76. Smr002530046

77. Am20090673

78. Sw219464-1

79. D03218

80. Ab01274739-01

81. Ab01274739_02

82. 460a850

83. Sr-01000941566

84. J-502064

85. Q-200662

86. Q4830631

87. Sr-01000941566-1

88. Brd-k29905972-001-01-4

89. Brd-k29905972-001-02-2

90. Benzamide, N-methyl-2-((3-((1e)-2-(2-pyridinyl)ethenyl)-1h-indazo)-6-yl)thio)-

91. N-methyl-[[3[(1e)-2-(2-pyridinyl)ethenyl]-1h-indazol-6-yl]thio]-benzamide

92. N-methyl-2((3-((1e0-2-(pyridin-2-yl)ethenyl)-1h-inazol-6-ylsufanyl)benzamide

93. N-methyl-2-({3-[(e)-2-pyridin-2-ylethenyl]-2h-indazol-6-yl}sulfanyl)benzamide

2.4 Create Date
2006-04-29
3 Chemical and Physical Properties
Molecular Weight 386.5 g/mol
Molecular Formula C22H18N4OS
XLogP34.2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass386.12013238 g/mol
Monoisotopic Mass386.12013238 g/mol
Topological Polar Surface Area96 Ų
Heavy Atom Count28
Formal Charge0
Complexity557
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameInlyta
PubMed HealthAxitinib (By mouth)
Drug ClassesAntineoplastic Agent
Drug LabelINLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structur...
Active IngredientAxitinib
Dosage FormTablet
RouteOral
Strength1mg; 5mg
Market StatusPrescription
CompanyPfizer

2 of 2  
Drug NameInlyta
PubMed HealthAxitinib (By mouth)
Drug ClassesAntineoplastic Agent
Drug LabelINLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide. The molecular formula is C22H18N4OS and the molecular weight is 386.47 Daltons. The chemical structur...
Active IngredientAxitinib
Dosage FormTablet
RouteOral
Strength1mg; 5mg
Market StatusPrescription
CompanyPfizer

4.2 Drug Indication

Used in kidney cell cancer and investigated for use/treatment in pancreatic and thyroid cancer.


FDA Label


Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Axitinib prevents the progression of cancer by inhibiting angiogenesis and blocking tumor growth.


5.2 MeSH Pharmacological Classification

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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
AXITINIB
5.3.2 FDA UNII
C9LVQ0YUXG
5.3.3 Pharmacological Classes
Receptor Tyrosine Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
5.4 ATC Code

L01EK01


L01XE17

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EK - Vascular endothelial growth factor receptor (vegfr) tyrosine kinase inhibitors

L01EK01 - Axitinib


5.5 Absorption, Distribution and Excretion

Absorption

After one 5 mg dose of axitinib, it takes about 2.5 to 4.1 hours to reach maximum plasma concentration.


Route of Elimination

Axitinib is mainly eliminated unchanged in the feces (41%) with 12% of the original dose as unchanged axitinib. There is also 23% eliminated in the urine, most of which are metabolites.


Volume of Distribution

The volume of distribution is 160 L.


Clearance

The average clearance of axitinib is 38 L/h.


5.6 Metabolism/Metabolites

Axitinib undergoes mainly hepatic metabolism. CYP3A4 and CYP3A5 are the main hepatic enzymes while CYP1A2, CYP2C19, and UGT1A1 enzymes are secondary.


5.7 Biological Half-Life

Axitinib has a half life of 2.5 to 6.1 hours.


5.8 Mechanism of Action

Axitinib selectively blocks the tyrosine kinase receptors VEGFR-1 (vascular endothelial growth factor receptor), VEGFR-2, and VEGFR-3.


USDMF

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Hetero Labs Ltd

India

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euroPLX 90 Lisbon
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 42016

Submission : 2025-11-05

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2016-09-16

Pay. Date : 2016-07-01

DMF Number : 30341

Submission : 2016-03-04

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2015-12-18

Pay. Date : 2015-09-23

DMF Number : 29672

Submission : 2015-09-29

Status : Active

Type : II

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DMF Review : Complete

Rev. Date : 2016-02-05

Pay. Date : 2015-12-23

DMF Number : 30104

Submission : 2015-12-24

Status : Active

Type : II

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Synthon Bv

Netherlands

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Synthon Bv

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GDUFA

DMF Review : Complete

Rev. Date : 2023-06-27

Pay. Date : 2023-02-06

DMF Number : 37971

Submission : 2023-02-02

Status : Active

Type : II

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DMF Number : 39323

Submission : 2023-12-27

Status : Active

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Apotex Inc

China

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Apotex Inc

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DMF Review : Complete

Rev. Date : 2016-04-15

Pay. Date : 2015-10-29

DMF Number : 29918

Submission : 2015-10-10

Status : Active

Type : II

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Axitinib IH

Date of Issue : 2025-08-22

Valid Till : 2028-08-21

Written Confirmation Number : WC-0082

Address of the Firm : Karakhadi, Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist -Vadodara, Gujara...

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Hetero Drugs

India
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Hetero Drugs

India
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Axitinib IH

Date of Issue : 2025-09-03

Valid Till : 2028-08-08

Written Confirmation Number : WC-0041

Address of the Firm : Unit-I, Sy. No. 10, I.D.A, Gaddapotharam (V), Jinnaram (M), Sangareddy District,...

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Axitinib IH

Date of Issue : 2025-09-19

Valid Till : 2028-05-05

Written Confirmation Number : WC-0349

Address of the Firm : Unit-II, Sy. Nos. 50, 53, 53/A, 54 & 54/A,Kardanur (Village), Patancheru (Mandal...

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Axitinib IH

Date of Issue : 2026-01-01

Valid Till : 2028-07-02

Written Confirmation Number : WC-0147

Address of the Firm : 100% EOU, Plot No.33, 33A, 40 to 47,Block C, D, E, H, I& AM,Raichur Industrial G...

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Pfizer Inc

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Pfizer Inc

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Axitinib

Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

Registration Date : 2018-02-08

Registration Number : Su87-23-ND

Manufacturer Name : Pfizer Ireland Pharmaceutica...

Manufacturer Address : Ringaskiddy API Plant, Ringaskiddy, Co. Cork, P43 X336, Ireland

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Pfizer Inc

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Axitinib

Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

Registration Date : 2012-08-06

Registration Number : Su189-15-ND

Manufacturer Name : Upjohn Manufacturing Ireland...

Manufacturer Address : Little Island Co. Cork, T45 F627, Ireland

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API Reference Price

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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"LABORATORIOS RICHMOND S A","customerCountry":"ARGENTINA","quantity":"0.37","actualQuantity":"0.37","unit":"KGS","unitRateFc":"37620","totalValueFC":"13729.8","currency":"N\/A","unitRateINR":3366990,"date":"30-Jan-2026","totalValueINR":"1245786.3","totalValueInUsd":"13729.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4527509","productDescription":"API","marketType":"","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1647369000,"product":"RE-IMPORTS- AXITINIB IMPURITY B (N.C.V )","address":"Z-A-1 BLOCK PART OF,APM-II,,PHASE- II, SEC-19B VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SC VEROPHARM","supplierCountry":"INDIA","foreign_port":"NA","customer":"THETABETA ANALGORITHMS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.3","unit":"GMS","unitRateFc":"16.7","totalValueFC":"5.1","currency":"USD","unitRateINR":"1291.8","date":"16-Mar-2022","totalValueINR":"387.55","totalValueInUsd":"5.1","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"7888041","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Z-A-1 BLOCK PART OF,APM-II,,PHASE- II, SEC-19B VASHI"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1647369000,"product":"RE-IMPORTS- AXITINIB IMPURITY C (N.C.V )","address":"Z-A-1 BLOCK PART OF,APM-II,,PHASE- II, SEC-19B VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SC VEROPHARM","supplierCountry":"INDIA","foreign_port":"NA","customer":"THETABETA ANALGORITHMS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.3","unit":"GMS","unitRateFc":"33.3","totalValueFC":"10.2","currency":"USD","unitRateINR":"2583.7","date":"16-Mar-2022","totalValueINR":"775.12","totalValueInUsd":"10.2","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"7888041","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Z-A-1 BLOCK PART OF,APM-II,,PHASE- II, SEC-19B VASHI"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1647369000,"product":"RE-IMPORTS- AXITINIB INHOUSE IMPURITY H (N.C.V )","address":"Z-A-1 BLOCK PART OF,APM-II,,PHASE- II, SEC-19B VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"SC VEROPHARM","supplierCountry":"INDIA","foreign_port":"NA","customer":"THETABETA ANALGORITHMS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.3","unit":"GMS","unitRateFc":"33.3","totalValueFC":"10.2","currency":"USD","unitRateINR":"2583.7","date":"16-Mar-2022","totalValueINR":"775.12","totalValueInUsd":"10.2","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"7888041","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Z-A-1 BLOCK PART OF,APM-II,,PHASE- II, SEC-19B VASHI"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1653417000,"product":"5G, AXITINIB, CAS(319460-85-0)98% QB-6040(FOR R & D TESTING PURPOSE)(1 NOS)","address":"PLOT NO B-11\/1,INDUSTRIAL DEVELOPM ENT AREA UPPAL","city":"HYDERABAD,TELANGANA","supplier":"COMBI BLOCKS INC","supplierCountry":"CHINA","foreign_port":"NA","customer":"CHEMVEDA LIFE SCIENCES INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"210","totalValueFC":"1293.4","currency":"USD","unitRateINR":"19992.9","date":"25-May-2022","totalValueINR":"99964.42","totalValueInUsd":"1293.4","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"8827557","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO B-11\/1,INDUSTRIAL DEVELOPM ENT AREA UPPAL"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766514600,"product":"AXITINIB 2R(100%EOU) FREE OF CHARGES AXITINIB 2R(100%EOU) FREE OF CHARGES","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"PFIZER IRELAND PHARMACEUTICALS","supplierCountry":"IRELAND","foreign_port":"BANGALORE","customer":"PFIZER HEALTHCARE INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"33898.1","totalValueFC":"10310.6","currency":"USD","unitRateINR":"3093205.7","date":"24-Dec-2025","totalValueINR":"927961.72","totalValueInUsd":"10310.6","indian_port":"Madras Air","hs_no":"29339990","bill_no":"190286","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE","supplierAddress":"P.O.BOX 140 RINGASKKIDDY CO,CORK , , IRELAND SDNF IRELAND","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"}]
15-Feb-2022
30-Jan-2026
KGS
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Average Price (USD/KGS)

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

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Drugs in Development

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Details:

OTX-TKI (Axitinib) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Diabetic Retinopathy.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: OTX-TKI

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 19, 2025

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01

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : OTX-TKI (Axitinib) is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Diabetic Retinopathy.

Product Name : OTX-TKI

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 19, 2025

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Details:

Sasanlimab is a Antibody drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Carcinoma, Renal Cell.


Lead Product(s): Sasanlimab,Palbociclib,Axitinib

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Antibody, Unconjugated

Sponsor: Stephanie Berg

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 14, 2025

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02

Pfizer Inc

U.S.A
arrow
euroPLX 90 Lisbon
Not Confirmed

Pfizer Inc

U.S.A
arrow
euroPLX 90 Lisbon
Not Confirmed

Details : Sasanlimab is a Antibody drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Carcinoma, Renal Cell.

Product Name : Undisclosed

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

August 14, 2025

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Details:

BL-B01D1 is a Other Large Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Kidney Neoplasms.


Lead Product(s): BL-B01D1,Axitinib,Pembrolizumab

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Baili-Bio (Chengdu) Pharmaceutical

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 08, 2025

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03

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Lead Product(s) : BL-B01D1,Axitinib,Pembrolizumab

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Baili-Bio (Chengdu) Pharmaceutical

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : BL-B01D1 is a Other Large Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Kidney Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 08, 2025

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Details:

CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: CLS-AX

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 06, 2025

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04

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.

Product Name : CLS-AX

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 06, 2025

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Details:

CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: CLS-AX

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 10, 2025

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05

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : CLS-AX (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of neovascular age-related macular degeneration.

Product Name : CLS-AX

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 10, 2025

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Details:

AIV001 (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of nonmelanoma skin cancer.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: IND EnablingProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 09, 2024

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06

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : AIV001 (axitinib) is a pan-tyrosine kinase inhibitor, small molecule drug candidate, which is being evaluated for the treatment of nonmelanoma skin cancer.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 09, 2024

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Details:

Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 15, 2024

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07

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.

Product Name : Axpaxli

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 15, 2024

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Details:

CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: CLS-AX

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 09, 2024

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08

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.

Product Name : CLS-AX

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 09, 2024

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Details:

CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: CLS-AX

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 27, 2024

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09

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : CLS-AX (axitinib injectable suspension) is a tyrosine kinase inhibitor (TKI), is under Phase 2b clinical trial for the treatment of wet AMD.

Product Name : CLS-AX

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 27, 2024

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Details:

Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.


Lead Product(s): Axitinib,Inapplicable

Therapeutic Area: Ophthalmology Brand Name: Axpaxli

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 07, 2024

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10

euroPLX 90 Lisbon
Not Confirmed
euroPLX 90 Lisbon
Not Confirmed

Details : Axpaxli (axitinib) is an investigational bioresorbable, hydrogel implant with axitinib, small molecule TKI with anti-angiogenic properties. It is being developed for the treatment of wet AMD.

Product Name : Axpaxli

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 07, 2024

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INTERMEDIATE SUPPLIERS

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01

Rampex Labs

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothRampex Labs – Simplifying Synthesis with Innovation, Quality, and Commitment to Global Pharmaceutical Excellence.

CAS Number : 2527-58-4

End Use API : Axitinib

About The Company : Rampex Labs, founded in 2004, is a fully cGMP-compliant pharmaceutical manufacturer with two USFDA-approved facilities in Hyderabad and Vizag, India. The Hydera...

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02

Epoch Labs

India
euroPLX 90 Lisbon
Not Confirmed
arrow

Epoch Labs

India
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 319460-85-0

End Use API : Axitinib

About The Company : Epoch-Labs is a Hyderabad, India based Research Organization that gives science administrations to expansive pharmaceutical organization, agrochemical organizat...

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03

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 944835-85-2

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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04

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 886230-77-9

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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05

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 261953-36-0

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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06

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 70315-70-7

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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07

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 2527-58-4

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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08

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 20054-45-9

End Use API : Axitinib

About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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09

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 20054-45-9

End Use API : Axitinib

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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10

euroPLX 90 Lisbon
Not Confirmed
arrow
euroPLX 90 Lisbon
Not Confirmed
arrow

CAS Number : 70315-70-7

End Use API : Axitinib

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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FDF Dossiers

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01

Apotex Inc

Canada
euroPLX 90 Lisbon
Not Confirmed
arrow

Apotex Inc

Canada
arrow
euroPLX 90 Lisbon
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date : 2025-10-30

Application Number : 211650

Regulatory Info : RX

Registration Country : USA

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02

Apotex Inc

Canada
euroPLX 90 Lisbon
Not Confirmed
arrow

Apotex Inc

Canada
arrow
euroPLX 90 Lisbon
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2025-10-30

Application Number : 211650

Regulatory Info : RX

Registration Country : USA

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03

euroPLX 90 Lisbon
Not Confirmed
arrow
arrow
euroPLX 90 Lisbon
Not Confirmed

Axitinib

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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04

euroPLX 90 Lisbon
Not Confirmed
arrow
arrow
euroPLX 90 Lisbon
Not Confirmed

Axitinib

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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05

euroPLX 90 Lisbon
Not Confirmed
arrow
arrow
euroPLX 90 Lisbon
Not Confirmed

Axitinib

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 7MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Turkey

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06

Pfizer Inc

U.S.A
euroPLX 90 Lisbon
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
euroPLX 90 Lisbon
Not Confirmed

AXITINIB

Brand Name : INLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date : 2012-01-27

Application Number : 202324

Regulatory Info : RX

Registration Country : USA

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07

Pfizer Inc

U.S.A
euroPLX 90 Lisbon
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
euroPLX 90 Lisbon
Not Confirmed

AXITINIB

Brand Name : INLYTA

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2012-01-27

Application Number : 202324

Regulatory Info : RX

Registration Country : USA

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08

Pfizer Inc

U.S.A
euroPLX 90 Lisbon
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
euroPLX 90 Lisbon
Not Confirmed

Axitinib

Brand Name : Inlyta

Dosage Form : Axitinib 1Mg 56 Combined Oral Use

Dosage Strength : 56 cpr riv 1 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

Sandoz B2B

Switzerland
euroPLX 90 Lisbon
Not Confirmed
arrow

Sandoz B2B

Switzerland
arrow
euroPLX 90 Lisbon
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 219705

Regulatory Info :

Registration Country : USA

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10

euroPLX 90 Lisbon
Not Confirmed
arrow
arrow
euroPLX 90 Lisbon
Not Confirmed

AXITINIB

Brand Name : AXITINIB

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 210234

Regulatory Info :

Registration Country : USA

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Looking for 319460-85-0 / Axitinib API manufacturers, exporters & distributors?

Axitinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Axitinib

Synonyms

319460-85-0, Ag-013736, Inlyta, Ag 013736, (e)-n-methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1h-indazol-6-yl)thio)benzamide, Ag-13736

Cas Number

319460-85-0

Unique Ingredient Identifier (UNII)

C9LVQ0YUXG

About Axitinib

A benzamide and indazole derivative that acts as a TYROSINE KINASE inhibitor of the VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR. It is used in the treatment of advanced RENAL CELL CARCINOMA.

Axitinib Manufacturers

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

Axitinib Suppliers

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

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

Axitinib USDMF

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

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

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

Axitinib KDMF

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

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

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

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

Axitinib WC

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

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

Axitinib 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 Axitinib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Axitinib GMP

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

Axitinib CoA

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

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

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