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ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 9 USDMF, 2 EU WC, 1 KDMF, 17 NDC API, 32 Listed Suppliers, $ API Reference Price

40 API Suppliers
9 USDMF
2 EU WC
1 KDMF
17 NDC API
32 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

61 Drugs in Development

61 Drugs in Development

INTERMEDIATES

22 Intermediates Suppliers

22 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

43 FDF Dossiers, 6 FDA Orange Book, 7 Europe, 18 Australia, 3 South Africa, 9 Listed Dossiers

43 FDF Dossiers
6 FDA Orange Book
7 Europe
18 Australia
3 South Africa
9 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 1 DKSH, 3 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 5 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 17 Kerry, 10 Microlex e.U, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 9 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 23 Direct Compression, 15 Disintegrants & Superdisintegrants, 14 Granulation, 13 Thickeners and Stabilizers, 12 Co-Processed Excipients, 12 Lubricants & Glidants, 7 Controlled & Modified Release, 6 Solubilizers, 3 Coating Systems & Additives, 3 Parenteral, 3 Emulsifying Agents, 2 Film Formers & Plasticizers, 2 Taste Masking, 2 Chewable & Orodispersible Aids, 1 API Stability Enhancers, 1 Rheology Modifiers

excipientsByApplications
46 Fillers, Diluents & Binders
23 Direct Compression
15 Disintegrants & Superdisintegrants
14 Granulation
13 Thickeners and Stabilizers
12 Co-Processed Excipients
12 Lubricants & Glidants
7 Controlled & Modified Release
6 Solubilizers
3 Coating Systems & Additives
3 Parenteral
3 Emulsifying Agents
2 Film Formers & Plasticizers
2 Taste Masking
2 Chewable & Orodispersible Aids
1 API Stability Enhancers
1 Rheology Modifiers

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 146 NEWS #PharmaBuzz

media
6 DATA COMPILATION #PharmaFlow
146 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 7 Finished Drug Prices, 10 Annual Reports

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

MARKET PLACE

23 APIs, 3 FDF Dossiers

marketPlace
23 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

179 US Patents, 38 US Exclusivities, 8 Health Canada Patents

patents
179 US Patents
38 US Exclusivities
8 Health Canada Patents

Granules Ruxolitinib Phosphate

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 30,277

MARKET PLACE

API

FDF

22INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

61DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

179

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

146

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

1,780,659,798

Annual Reports (USD Million)

10,014

Finished Drug Prices

103 RELATED EXCIPIENT COMPANIES

165EXCIPIENTS BY APPLICATIONS

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 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 Formula	C₁₇H₂₁N₆O₄P
Molecular Weight	404.4 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	4
Exact Mass	404.13619017 g/mol
Monoisotopic Mass	404.13619017 g/mol
Topological Polar Surface Area	161 Å²
Heavy Atom Count	28
Formal Charge	0
Complexity	503
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Jakafi
PubMed Health	Ruxolitinib (By mouth)
Drug Classes	Antineoplastic Agent
Active Ingredient	Ruxolitinib phosphate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base
Market Status	Prescription
Company	Incyte

2 of 2
Drug Name	Jakafi
PubMed Health	Ruxolitinib (By mouth)
Drug Classes	Antineoplastic Agent
Active Ingredient	Ruxolitinib phosphate
Dosage Form	Tablet
Route	Oral
Strength	eq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base
Market Status	Prescription
Company	Incyte

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

API SUPPLIERS

01

Granules India Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Transo-Pharm USA LLC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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U.S.A

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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U.S.A

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04

Metrochem API Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

05

Inabata France S.A.S

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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France

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06

Seqens

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

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07

Faran Shimi Pharmaceutical

Iran

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Iran

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Corporate PDF

08

Shandong Chenghui Shuangda Pharmac...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI China

Attending

Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

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China

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Shandong Chenghui Shuangda Pharmaceutical

09

Aarti Pharmalabs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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India

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10

Jinan Tantu Chemicals

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI China

Exhibiting

Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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China

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API Reference Price

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C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"REYES","customer":"CORIPHARMA","customerCountry":"ICELAND","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"30000","totalValueFC":"15008","currency":"USD","unitRateINR":2236000,"date":"06-Jan-2022","totalValueINR":"1118000","totalValueInUsd":"15008","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"7300503","productDescription":"API","marketType":"REGULATED MARKET","country":"ICELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645554600,"product":"RUXOLITINIB PHOSPHATE (TAX INV NO:190521","address":"MSN HOUSE, PLOT NO. 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