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Chemistry

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Also known as: 635702-64-6, Pazopanib hcl, Votrient, Pazopanib (hydrochloride), Armala, Unii-33y9anm545
Molecular Formula
C21H24ClN7O2S
Molecular Weight
474.0  g/mol
InChI Key
MQHIQUBXFFAOMK-UHFFFAOYSA-N
FDA UNII
33Y9ANM545

Pazopanib Hydrochloride
Pazopanib Hydrochloride is the hydrochloride salt of a small molecule inhibitor of multiple protein tyrosine kinases with potential antineoplastic activity. Pazopanib selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2 and -3, c-kit and platelet derived growth factor receptor (PDGF-R), which may result in inhibition of angiogenesis in tumors in which these receptors are upregulated.
1 2D Structure

Pazopanib Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-[[4-[(2,3-dimethylindazol-6-yl)-methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide;hydrochloride
2.1.2 InChI
InChI=1S/C21H23N7O2S.ClH/c1-13-5-6-15(11-19(13)31(22,29)30)24-21-23-10-9-20(25-21)27(3)16-7-8-17-14(2)28(4)26-18(17)12-16;/h5-12H,1-4H3,(H2,22,29,30)(H,23,24,25);1H
2.1.3 InChI Key
MQHIQUBXFFAOMK-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C=C(C=C1)NC2=NC=CC(=N2)N(C)C3=CC4=NN(C(=C4C=C3)C)C)S(=O)(=O)N.Cl
2.2 Other Identifiers
2.2.1 UNII
33Y9ANM545
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gw 780604

2. Gw 786034b

3. Gw-780604

4. Gw-786034b

5. Gw780604

6. Gw786034b

7. Pazopanib

8. Votrient

2.3.2 Depositor-Supplied Synonyms

1. 635702-64-6

2. Pazopanib Hcl

3. Votrient

4. Pazopanib (hydrochloride)

5. Armala

6. Unii-33y9anm545

7. Pazopanib Monohydrochloride

8. Pazopanib Hcl (gw786034 Hcl)

9. Gw786034b

10. Gw-786034b

11. Pazopanib (as Hydrochloride)

12. Gw786034 (hydrochloride)

13. 5-[[4-[(2,3-dimethylindazol-6-yl)-methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide;hydrochloride

14. Chebi:71217

15. 33y9anm545

16. S1035

17. 5-((4-((2,3-dimethyl-2h-indazol-6-yl)(methyl)amino)pyrimidin-2-yl)amino)-2-methylbenzenesulfonamide Hydrochloride

18. 5-((4-((2,3-dimethyl-2h-indazol-6-yl)methylamino)pyrimidin-2-yl)amino)-2-methylbenzenesulfonamide Monohydrochloride

19. 5-({4-[(2,3-dimethyl-2h-indazol-6-yl)(methyl)amino]pyrimidin-2-yl}amino)-2-methylbenzene-1-sulfonamide Hydrochloride

20. 5-{4-[(2,3-dimethyl-2h-indazol-6-yl)-methyl-amino]-pyrimidin-2-ylamino}-2-methyl-benzenesulfonamide Hydrochloride

21. Benzenesulfonamide, 5-((4-((2,3-dimethyl-2h-indazol-6-yl)methylamino)-2-pyrimidinyl)amino)-2-methyl-, Monohydrochloride

22. Patorma

23. Gw786034 Hcl

24. Votrient Hcl

25. Votrient (tn)

26. 5-({4-[(2,3-dimethyl-2h-indazol-6-yl)(methyl)amino]pyrimidin-2-yl}amino)-2-methylbenzenesulfonamide Hydrochloride

27. Pazopanib Hydrochloride [usan:jan]

28. Mls004774147

29. Schembl159487

30. Pazopanib Hydrochloride- Bio-x

31. Pazopanib Hydrochloride [usan]

32. Chembl1201733

33. Dtxsid70212956

34. Ex-a956

35. Pazopanib Hcl (gw786034 )

36. Bcp02203

37. Pazopanib Hydrochloride (jan/usan)

38. Pazopanib Hydrochloride [mi]

39. Mfcd12546138

40. Nsc737754

41. Pazopanib Hydrochloride [jan]

42. Akos015958593

43. Bcp9001052

44. Ccg-269485

45. Cs-0126

46. Gsk-786034

47. Ks-1458

48. Nsc-737754

49. Pazopanib Hydrochloride [mart.]

50. Pb31655

51. Sb10367

52. Pazopanib Hydrochloride [who-dd]

53. Ac-24726

54. Bp166746

55. Hy-12009

56. Smr003500790

57. Am20090655

58. Ft-0687642

59. P2243

60. Pazopanib Hydrochloride [orange Book]

61. Sw218082-2

62. Ec-000.2347

63. D05380

64. A834417

65. Q27888072

66. 5-({4-[(2,3-dimethyl-2h-indazol-6-yl)(methyl)amino]-2-pyrimidinyl}amino)-2-methylbenzenesulfonamide Hydrochloride

67. 5-(4-((2,3-dimethyl-2h-indazol-6-yl)(methyl)amino)pyrimidin-2-ylamino)-2-methylbenzenesulfonamide Hydrochloride

68. 5-(4-((2,3-dimethyl-2h-indazol-6-yl)(methyl)amino)pyrimidin-2-ylamino)-2-methylbenzenesulfonamide Hydrochloride;5-[[4-[(2,3-dimethylindazol-6-yl)-methyl-amino]pyrimidin-2-yl]amino]-2-methyl-benzenesulfonamide Hydrochloride

69. 5-[[4-[(2,3-dimethylindazol-6-yl)-methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide Hydrochloride

70. Benzenesulfonamide, 5-[[4-[(2,3-dimethyl-2h-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methyl-, Hydrochloride (1:1)

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 474.0 g/mol
Molecular Formula C21H24ClN7O2S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count5
Exact Mass473.1400719 g/mol
Monoisotopic Mass473.1400719 g/mol
Topological Polar Surface Area127 Ų
Heavy Atom Count32
Formal Charge0
Complexity717
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameVotrient
PubMed HealthPazopanib (By mouth)
Drug ClassesAntineoplastic Agent, Immunological Agent
Active IngredientPazopanib hydrochloride
Dosage FormTablet
RouteOral
Strengtheq 200mg base; eq 400mg base
Market StatusPrescription
CompanyGlaxosmithkline

2 of 2  
Drug NameVotrient
PubMed HealthPazopanib (By mouth)
Drug ClassesAntineoplastic Agent, Immunological Agent
Active IngredientPazopanib hydrochloride
Dosage FormTablet
RouteOral
Strengtheq 200mg base; eq 400mg base
Market StatusPrescription
CompanyGlaxosmithkline

4.2 Drug Indication

* Renal-cell carcinoma (RCC):

Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.

* Soft-tissue sarcoma (STS):

Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy.

Efficacy and safety have only been established in certain STS histological tumour subtypes.


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; Kinase Inhibitor [EPC]; Protein Kinase Inhibitors [MoA]; Cytochrome P450 2C8 Inhibitors [MoA]
5.2 ATC Code

L01XE11


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Rev. Date : 2021-11-29

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DMF Number : 36192

Submission : 2021-10-04

Status : Active

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Pay. Date : 2013-05-17

DMF Number : 26207

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DMF Number : 27422

Submission : 2013-08-31

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Pazopanib Hydrochloride

Registration Number : 307MF10025

Registrant's Address : No. 29 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, Chin...

Initial Date of Registration : 2025-02-07

Latest Date of Registration : 2025-02-07

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Pazopanib HCl IH

Date of Issue : 2019-01-14

Valid Till : 2021-07-15

Written Confirmation Number : WC-0327

Address of the Firm : No.116/117 KIADB Industial area, Jigani, Bangalore-560105 Karnataka

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Cdymax

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Pazopanib HCl IH

Date of Issue : 2024-11-28

Valid Till : 2024-07-15

Written Confirmation Number : WC-0327n

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

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Cipla

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Pazopanib Hydrochloride

Date of Issue : 2022-11-09

Valid Till : 2025-08-08

Written Confirmation Number : WC-0138

Address of the Firm : Plot No. 285, 286 & 287, Bommasandra-Jigani Link Road, Industrial Area, KIADB, 4...

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Pazopanib HCl IH

Date of Issue : 2021-07-09

Valid Till : 2022-08-08

Written Confirmation Number : WC-0138A3

Address of the Firm : Plot No. 285, 286 & 287, Bommasandra-Jigani Link Road, Industrial Area, KIADB, 4...

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Hetero Drugs

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Pazopanib Hydrochloride (1H)

Date of Issue : 2022-09-16

Valid Till : 2025-08-08

Written Confirmation Number : WC-0041

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

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Laurus Labs

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Pazopanib Hydrochloride In house

Date of Issue : 2023-07-03

Valid Till : 2025-07-02

Written Confirmation Number : WC-0213

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

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Pazopanib Hydrochloride (IHS)

Date of Issue : 2022-09-02

Valid Till : 2025-05-05

Written Confirmation Number : WC-0349

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

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Pazopanib hydrochloride

Registrant Name : Novartis Korea Ltd.

Registration Date : 2023-07-12

Registration Number : 196-26-ND

Manufacturer Name : FIS Fabbrica Italiana Sintet...

Manufacturer Address : Viale Milano, 26, 36075 Montecchio Maggiore (Vicenza), Italy@Crossways Boulevard, Cro...

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Pazopanib hydrochloride

Registrant Name : 엠피크코리아(주)

Registration Date : 2020-10-21

Registration Number : Number 812-12-ND

Manufacturer Name : Formosa Laboratories, Inc.

Manufacturer Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan

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GSK

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Pazopanib hydrochloride

Registrant Name : Novartis Korea Ltd.

Registration Date : 2012-07-31

Registration Number : 89-11-ND

Manufacturer Name : Glaxo Wellcome Manufacturing...

Manufacturer Address : 1 Pioneer Sector 1, Jurong, Singapore 628413@[Undifferentiated Manufacturer] Crossway...

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Pazopanib hydrochloride

Registrant Name : Klasia Co., Ltd.

Registration Date : 2021-10-25

Registration Number : No. 758-8-ND

Manufacturer Name : Kekule Pharma Limited

Manufacturer Address : MIA, Kazipally, Jinnaram Mandal, Sangareddy-502 319, Telangana State, India

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Pazopanib hydrochloride

Registrant Name : Novartis Korea Ltd.

Registration Date : 2021-03-23

Registration Number : 196-22-ND

Manufacturer Name : Thermo Fisher Scientific Cor...

Manufacturer Address : Currabinny, Carrigaline, County Cork, P43 AY66, Ireland@Crossways Boulevard, Crossway...

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NDC Package Code : 16436-0125

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NDC Package Code : 62207-977

Start Marketing Date : 2021-08-09

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NDC Package Code : 53104-7727

Start Marketing Date : 2019-02-04

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NDC Package Code : 66499-0055

Start Marketing Date : 2012-04-23

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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NDC Package Code : 68554-0058

Start Marketing Date : 2009-10-19

End Marketing Date : 2025-12-31

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NDC Package Code : 54893-0014

Start Marketing Date : 2009-10-19

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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NDC Package Code : 76055-0050

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NDC Package Code : 68578-0015

Start Marketing Date : 2021-09-15

End Marketing Date : 2025-12-31

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

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Pazopanib Hydrochloride

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
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About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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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...

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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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Pazopanib Hydrochloride

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 & 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 & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Pazopanib Hydrochloride

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.
Medichem

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Virtual BoothShandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

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Pazopanib Hydrochloride

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 BoothTagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.

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Pazopanib Hydrochloride

About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...

Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-growth therapeutic areas, with an emphasis on affordability, quality and timely delivery. It also provides end-to-end CDMO services. Headquartered in Hyderabad, Tagoor Labs is a fast-growing Indian pharma company that serves both branded and generic companies worldwide. The company’s organizational function includes R&D, supply chain, manufacturing, quality testing, quality assurance, regulatory affairs, marketing & sales, and packaging & warehousing departments.
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Pazopanib Hydrochloride

About the Company : Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufact...

Granules is a fast-growing, vertically integrated pharmaceutical company headquartered in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain—APIs, Formulation Intermediates, & Formulations. With 10 facilities (8 in India, 2 in the US) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & the UK, ensuring a strong global presence.Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.
Granules India

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Pazopanib Hydrochloride

About the Company : Acebright ensures and adherence to HSE practices. Our infrastructure for oncology APIs supports capacity of 35MTs plus annually, having line 1 (20MTs) & line 2 (15MTs) separately. ...

Acebright ensures and adherence to HSE practices. Our infrastructure for oncology APIs supports capacity of 35MTs plus annually, having line 1 (20MTs) & line 2 (15MTs) separately. Our General APIs facility has capacity of 200MTs plus annually, with line 1 (110MTs) and Line 2 (90MTs) separately.
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10-Feb-2025
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DOSAGE - TABLET;ORAL - EQ 200MG BASE

USFDA APPLICATION NUMBER - 22465

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DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22465

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ABOUT THIS PAGE

Looking for 635702-64-6 / Pazopanib Hydrochloride API manufacturers, exporters & distributors?

Pazopanib Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pazopanib Hydrochloride

Synonyms

635702-64-6, Pazopanib hcl, Votrient, Pazopanib (hydrochloride), Armala, Unii-33y9anm545

Cas Number

635702-64-6

Unique Ingredient Identifier (UNII)

33Y9ANM545

About Pazopanib Hydrochloride

Pazopanib Hydrochloride is the hydrochloride salt of a small molecule inhibitor of multiple protein tyrosine kinases with potential antineoplastic activity. Pazopanib selectively inhibits vascular endothelial growth factor receptors (VEGFR)-1, -2 and -3, c-kit and platelet derived growth factor receptor (PDGF-R), which may result in inhibition of angiogenesis in tumors in which these receptors are upregulated.

Pazopanib Hydrochloride Manufacturers

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

Pazopanib Hydrochloride Suppliers

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

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

Pazopanib Hydrochloride USDMF

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

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

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

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

Pazopanib Hydrochloride KDMF

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

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

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

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

Pazopanib Hydrochloride WC

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

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

Pazopanib Hydrochloride 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 Pazopanib Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pazopanib Hydrochloride GMP

Pazopanib Hydrochloride 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 Pazopanib Hydrochloride 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 Pazopanib Hydrochloride GMP manufacturer or Pazopanib Hydrochloride GMP API supplier for your needs.

Pazopanib Hydrochloride CoA

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

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

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