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Chemistry

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Also known as: 1092939-17-7, Jakafi, (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate, Jakavi, Ruxolitinib (phosphate), Ruxolitinib monophosphate
Molecular Formula
C17H21N6O4P
Molecular Weight
404.4  g/mol
InChI Key
JFMWPOCYMYGEDM-XFULWGLBSA-N
FDA UNII
436LRU32H5

Ruxolitinib Phosphate
Ruxolitinib Phosphate is the phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation. The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies.
1 2D Structure

Ruxolitinib Phosphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile;phosphoric acid
2.1.2 InChI
InChI=1S/C17H18N6.H3O4P/c18-7-5-15(12-3-1-2-4-12)23-10-13(9-22-23)16-14-6-8-19-17(14)21-11-20-16;1-5(2,3)4/h6,8-12,15H,1-5H2,(H,19,20,21);(H3,1,2,3,4)/t15-;/m1./s1
2.1.3 InChI Key
JFMWPOCYMYGEDM-XFULWGLBSA-N
2.1.4 Canonical SMILES
C1CCC(C1)C(CC#N)N2C=C(C=N2)C3=C4C=CNC4=NC=N3.OP(=O)(O)O
2.1.5 Isomeric SMILES
C1CCC(C1)[C@@H](CC#N)N2C=C(C=N2)C3=C4C=CNC4=NC=N3.OP(=O)(O)O
2.2 Other Identifiers
2.2.1 UNII
436LRU32H5
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3r)-3-cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)pyrazol-1-yl)propanenitrile

2. Inc-424

3. Inc424

4. Inca24

5. Incb-018424

6. Incb-018424 Phosphate

7. Incb-018424 Salt

8. Incb-18424

9. Incb-18424 Phosphate

10. Incb018424

11. Incb018424 Phosphate

12. Jakafi

13. Jakavi

14. Opzelura

15. Ruxolitinib

16. Ruxolitinib (as Phosphate)

17. Ruxolitinib Monophosphate

2.3.2 Depositor-Supplied Synonyms

1. 1092939-17-7

2. Jakafi

3. (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile Phosphate

4. Jakavi

5. Ruxolitinib (phosphate)

6. Ruxolitinib Monophosphate

7. Incb018424 Phosphate

8. Ruxolitinib (as Phosphate)

9. Incb-018424 Phosphate

10. Incb-018424 Salt

11. Ruxolitinib Phosphate [usan]

12. Incb-18424 Phosphate

13. Incb018424 Salt

14. Chebi:66917

15. 436lru32h5

16. 1092939-17-7 (phosphate)

17. (betar)-beta-cyclopentyl-4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazole-1-propanenitrile Phosphate

18. Incb-18424

19. Ruxolitinib Phosphate Salt

20. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrile Phosphate

21. (3r)-3-cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile Phosphate (1:1)

22. Phosphenoperoxoic Acid Compound With (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)- 1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile And Dihydrogen (1:1:1)

23. Opzelura

24. Unii-436lru32h5

25. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrilephosphoricacid

26. Jakafi (tn)

27. Jakavi (tn)

28. Ruxolitinib Phosphate(incb018424)

29. Inc 424 Phosphate

30. Incb 018424 Phosphate

31. Incb-424

32. Schembl1369365

33. Chembl1795071

34. Amy5620

35. Dtxsid00911086

36. Ruxolitinib Phosphate (jan/usan)

37. Ruxolitinib Phosphate [mi]

38. Ruxolitinib Phosphate [jan]

39. Ex-a2660

40. Cs1956

41. Mfcd18452860

42. S5243

43. Akos024464417

44. Ruxolitinib (incb-18424) Phosphate

45. Ruxolitinib Phosphate [who-dd]

46. Bcp9000783

47. Ccg-268687

48. Cs-0326

49. 1h-pyrazole-1-propanenitrile, Beta-cyclopentyl-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betar)-, Phosphate (1:1)

50. Ac-30901

51. As-74723

52. Hy-50858

53. Ruxolitinib Phosphate [orange Book]

54. Ruxolitinib (as Phosphate) [ema Epar]

55. D09960

56. J-501793

57. Q27135517

58. (3r)-3-cyclopentyl-3-(4-{7h-pyrrolo[2,3-d]pyrimidin-4-yl}-1h-pyrazol-1-yl)propanenitrile; Phosphoric Acid

59. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile;phosphoric Acid

60. (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate

61. 1h-pyrazole-1-propanenitrile,.beta.-cyclopentyl-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,(.beta.r)-,phosphate (1:1)

62. Phosphoric Acid--3-cyclopentyl-3-[4-(1h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrile (1/1)

2.4 Create Date
2009-01-19
3 Chemical and Physical Properties
Molecular Weight 404.4 g/mol
Molecular Formula C17H21N6O4P
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count8
Rotatable Bond Count4
Exact Mass404.13619017 g/mol
Monoisotopic Mass404.13619017 g/mol
Topological Polar Surface Area161 Ų
Heavy Atom Count28
Formal Charge0
Complexity503
Isotope Atom Count0
Defined Atom Stereocenter Count1
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 NameJakafi
PubMed HealthRuxolitinib (By mouth)
Drug ClassesAntineoplastic Agent
Active IngredientRuxolitinib phosphate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base
Market StatusPrescription
CompanyIncyte

2 of 2  
Drug NameJakafi
PubMed HealthRuxolitinib (By mouth)
Drug ClassesAntineoplastic Agent
Active IngredientRuxolitinib phosphate
Dosage FormTablet
RouteOral
Strengtheq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base
Market StatusPrescription
CompanyIncyte

4.2 Drug Indication

* Myelofibrosis (MF):

Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

* Polycythaemia vera (PV):

Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.

* Graft versus host disease (GvHD):

Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5. 1).


Treatment of chronic Graft versus Host Disease (cGvHD)


Treatment of acute graft-versus-host disease (aGvHD)


Treatment of vitiligo


5 Pharmacology and Biochemistry
5.1 ATC Code

L01EJ01


FDA Orange Book

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Ruxolitinib

Brand Name : Ruxolitinib

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG

Approval Date :

Application Number : 219660

RX/OTC/DISCN :

RLD :

TE Code :

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Ruxolitinib

Brand Name : Ruxolitinib

Dosage Form : TABLET; ORAL

Dosage Strength : 15MG

Approval Date :

Application Number : 219660

RX/OTC/DISCN :

RLD :

TE Code :

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Ruxolitinib

Brand Name : Ruxolitinib

Dosage Form : TABLET; ORAL

Dosage Strength : 2MG

Approval Date :

Application Number : 219660

RX/OTC/DISCN :

RLD :

TE Code :

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RUXOLITINIB PHOSPHATE

Brand Name : JAKAFI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2011-11-16

Application Number : 202192

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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INCYTE CORP

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RUXOLITINIB PHOSPHATE

Brand Name : JAKAFI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2011-11-16

Application Number : 202192

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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RUXOLITINIB PHOSPHATE

Brand Name : JAKAFI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 15MG BASE

Approval Date : 2011-11-16

Application Number : 202192

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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RUXOLITINIB PHOSPHATE

Brand Name : JAKAFI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 20MG BASE

Approval Date : 2011-11-16

Application Number : 202192

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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RUXOLITINIB PHOSPHATE

Brand Name : JAKAFI

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2011-11-16

Application Number : 202192

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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RUXOLITINIB PHOSPHATE

Brand Name : OPZELURA

Dosage Form : CREAM;TOPICAL

Dosage Strength : EQ 1.5% BASE

Approval Date : 2021-09-21

Application Number : 215309

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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RUXOLITINIB

Brand Name : RUXOLITINIB

Dosage Form : TABLET

Dosage Strength : 10MG

Approval Date :

Application Number : 220375

RX/OTC/DISCN :

RLD :

TE Code :

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Brand Name : Jakavi

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 27/12/2012

Application Number : 62126

Regulatory Info : Allowed

Registration Country : Switzerland

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Ruxolitinib phosphate

Brand Name : Jakavi

Dosage Form : Tablet

Dosage Strength : 15mg

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Regulatory Info : Marketed

Registration Country : Norway

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Brand Name : Jakavi

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Registration Country : Norway

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Brand Name : Jakavi

Dosage Form : Tablet

Dosage Strength : 10mg

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Regulatory Info : Prescription

Registration Country : Estonia

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Brand Name : Jakavi

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Registration Country : Estonia

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Brand Name : Jakavi

Dosage Form : Tablet

Dosage Strength : 20mg

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Brand Name : Jackavi

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 07-10-2014

Application Number : 28105381014

Regulatory Info : Prescription

Registration Country : Denmark

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Ruxolitinib Phosphate

Brand Name : Jakavi

Dosage Form : Tablet

Dosage Strength : 5mg

Packaging :

Approval Date : 23-08-2012

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : Jakavi

Dosage Form : Tablet

Dosage Strength : 20mg

Packaging :

Approval Date : 23-08-2012

Application Number : 2.01E+13

Regulatory Info : Approved

Registration Country : Sweden

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Ruxolitinib Phosphate

Brand Name : Jakavi

Dosage Form : Oral Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 13-01-2025

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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Brand Name : OPZELURA

Dosage Form : CREAM

Dosage Strength : 1.5%/W/W

Packaging :

Approval Date :

Application Number : 2552434

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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RUXOLITINIB (RUXOLITINIB PHOSPHATE)

Brand Name : JAKAVI

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging : 56/60

Approval Date :

Application Number : 2388006

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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Brand Name : JAKAVI

Dosage Form : TABLET

Dosage Strength : 15MG

Packaging : 56/60

Approval Date :

Application Number : 2388014

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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Brand Name : JAKAVI

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging : 56/60

Approval Date :

Application Number : 2388022

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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RUXOLITINIB (RUXOLITINIB PHOSPHATE)

Brand Name : JAKAVI

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging : 4X14/60

Approval Date :

Application Number : 2434814

Regulatory Info : PRESCRIPTION

Registration Country : Canada

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Registration Country : Australia

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Brand Name : Jakavi

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Registration Country : Australia

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Registration Country : Australia

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Registration Country : Australia

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Registration Country : Australia

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Packaging : 56

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Registration Country : Australia

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Novartis South Africa (Pty) Ltd

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Ruxolitinib phosphate

Brand Name : Jakavi 20 mg

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 56X1mg

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Regulatory Info : Originator

Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Ruxolitinib phosphate

Brand Name : Jakavi 15 mg

Dosage Form : TAB

Dosage Strength : 15mg

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Registration Country : South Africa

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Novartis South Africa (Pty) Ltd

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Ruxolitinib phosphate

Brand Name : Jakavi 5 mg

Dosage Form : TAB

Dosage Strength : 5mg

Packaging : 56X1mg

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Regulatory Info : Originator

Registration Country : South Africa

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NanoAlvand

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Ruxolitinib Phosphate

Brand Name : Relata

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

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NanoAlvand

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Packaging :

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Ruxolitinib Phosphate

Dosage : Tablet

Dosage Strength : 5MG

Brand Name : Relata

Approval Date :

Application Number :

Registration Country : Iran

NanoAlvand

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NanoAlvand

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Regulatory Info :

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Ruxolitinib Phosphate

Brand Name : Relata

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

02

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Packaging :

Regulatory Info :

Ruxolitinib Phosphate

Dosage : Tablet

Dosage Strength : 10MG

Brand Name : Relata

Approval Date :

Application Number :

Registration Country : Iran

NanoAlvand

03

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Ruxolitinib Phosphate

Brand Name : Relata

Dosage Form : Tablet

Dosage Strength : 15MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

03

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Packaging :

Regulatory Info :

Ruxolitinib Phosphate

Dosage : Tablet

Dosage Strength : 15MG

Brand Name : Relata

Approval Date :

Application Number :

Registration Country : Iran

NanoAlvand

04

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Ruxolitinib Phosphate

Brand Name : Relata

Dosage Form : Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

04

NanoAlvand

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Flag Iran
Digital Content Digital Content

Packaging :

Regulatory Info :

Ruxolitinib Phosphate

Dosage : Tablet

Dosage Strength : 20MG

Brand Name : Relata

Approval Date :

Application Number :

Registration Country : Iran

NanoAlvand
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ABOUT THIS PAGE

Looking for 1092939-17-7 / Ruxolitinib Phosphate API manufacturers, exporters & distributors?

Ruxolitinib Phosphate manufacturers, exporters & distributors 1

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

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

API | Excipient name

Ruxolitinib Phosphate

Synonyms

1092939-17-7, Jakafi, (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate, Jakavi, Ruxolitinib (phosphate), Ruxolitinib monophosphate

Cas Number

1092939-17-7

Unique Ingredient Identifier (UNII)

436LRU32H5

About Ruxolitinib Phosphate

Ruxolitinib Phosphate is the phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation. The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies.

Ruxolitinib Phosphate Manufacturers

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

Ruxolitinib Phosphate Suppliers

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

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

Ruxolitinib Phosphate USDMF

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

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

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

Ruxolitinib Phosphate KDMF

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

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

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

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

Ruxolitinib Phosphate WC

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

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

Ruxolitinib Phosphate 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 Ruxolitinib Phosphate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ruxolitinib Phosphate GMP

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

Ruxolitinib Phosphate CoA

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

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

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