Synopsis
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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
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)
Molecular Weight | 404.4 g/mol |
---|---|
Molecular Formula | C17H21N6O4P |
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 Ų |
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 |
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 |
* 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
L01EJ01
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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
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Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
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1-(1-ethoxyethyl)-4-(4,4,5,5- tetramethyl-1,3,2-di...
CAS Number : 1029716-44-6
End Use API : Ruxolitinib Phosphate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
CAS Number : 591769-05-0
End Use API : Ruxolitinib Phosphate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
(4-(1-(2-Cyano-1- cyclopentylethyl)-1h-pyrazol-4-y...
CAS Number : 1236033-05-8
End Use API : Ruxolitinib Phosphate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
1-(1-Ethoxyethyl)-4-(4,4,5,5-tetramethyl[1,3,2]dio...
CAS Number : 1029716-44-6
End Use API : Ruxolitinib Phosphate
About The Company : Allsino Pharmaceutical, established in May 2004, spans 97,350m² and specializes in the R&D and manufacturing of RSMs, GMP intermediates, and APIs. Our products...
4-Chloro-7H-pyrrolo-[2,3-d]pyrimidine
CAS Number : 3680-69-1
End Use API : Ruxolitinib Phosphate
About The Company : Allsino Pharmaceutical, established in May 2004, spans 97,350m² and specializes in the R&D and manufacturing of RSMs, GMP intermediates, and APIs. Our products...
4-Methyl-7-H-pyrrolo[2,3-d]pyrimidine
CAS Number : 945950-37-8
End Use API : Ruxolitinib Phosphate
About The Company : Allsino Pharmaceutical, established in May 2004, spans 97,350m² and specializes in the R&D and manufacturing of RSMs, GMP intermediates, and APIs. Our products...
3,7-Dihydro-4H-Pyrrolo[2,3-d] Pyrimidin-4-One
CAS Number : CAS-3680-71-5
End Use API : Ruxolitinib Phosphate
About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...
CAS Number : 591769-05-0
End Use API : Ruxolitinib Phosphate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
CAS Number : 1193-24-4
End Use API : Ruxolitinib Phosphate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
CAS Number : 2075-45-8
End Use API : Ruxolitinib Phosphate
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Ruxolitinib Phosphate
Dosage Form : Immediate Release Tablet
Dosage Strength : 4.71%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Jakavi 20 mg
Dosage Form : TAB
Dosage Strength : 20mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Antic-calc Tablet
Dosage Strength : 15 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Antic-calc Tablet
Dosage Strength : 20 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Antic-calc Tablet
Dosage Strength : 5 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 5MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 15MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 20MG
Brand Name : Relata
Approval Date :
Application Number :
Registration Country : Iran
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Ruxolitinib Phosphate
Dosage Form : Immediate Release Tabl...
Dosage Strength : 4.71%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Packaging :
Regulatory Info :
Dosage : Immediate Release Tabl...
Dosage Strength : 4.71%
Brand Name : Ruxolitinib Phosphate
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 2MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 15MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Cream
Dosage Strength : 1.5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Packaging :
Regulatory Info :
Dosage : Cream
Dosage Strength : 1.5%
Brand Name :
Approval Date :
Application Number :
Registration Country : Spain
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Comprecel M102, M102CG, M103, M105, M124, M113, M200, M224, M301, M302
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : It is used as a lubricant.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Magnesium Stearate
Excipients by Applications
Global Sales Information
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 1,339
2019 Revenue in Millions : 1,114
Growth (%) : 20
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 1,595
2020 Revenue in Millions : 1,339
Growth (%) : 19
Main Therapeutic Indication : Hematology
Currency : USD
2022 Revenue in Millions : 1,561
2021 Revenue in Millions : 1,595
Growth (%) : -2
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 1,720
2022 Revenue in Millions : 1,561
Growth (%) : 10
Main Therapeutic Indication : Oncology
Currency : USD
2024 Revenue in Millions : 1,936
2023 Revenue in Millions : 1,720
Growth (%) : 13
Main Therapeutic Indication : Oncology
Currency : USD
2014 Revenue in Millions : 71.20%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Oncology
Currency : USD
2015 Revenue in Millions : 279
2014 Revenue in Millions : 410
Growth (%) : 47%
Main Therapeutic Indication : Oncology
Currency : USD
2016 Revenue in Millions : 581
2015 Revenue in Millions : 410
Growth (%) : 42
Main Therapeutic Indication : Oncology
Currency : USD
2017 Revenue in Millions : 777
2016 Revenue in Millions : 581
Growth (%) : 34
Main Therapeutic Indication : Oncology
Currency : USD
2018 Revenue in Millions : 977
2017 Revenue in Millions : 777
Growth (%) : 26%
Market Place
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2027-12-24
US Patent Number : 7598257
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202192
Patent Use Code : U-3227
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-12-24
Patent Expiration Date : 2028-06-12
US Patent Number : 8829013
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code : U-1201
Delist Requested :
Patent Use Description : FOR THE TREATMENT OF I...
Patent Expiration Date : 2028-06-12
Patent Expiration Date : 2028-12-12
US Patent Number : 8822481*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-12-12
Patent Expiration Date : 2027-12-24
US Patent Number : 7598257
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202192
Patent Use Code : U-3227
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-12-24
Patent Expiration Date : 2028-12-12
US Patent Number : 10610530*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-12-12
Patent Expiration Date : 2028-06-12
US Patent Number : 10610530
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code : U-3229
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-06-12
Patent Expiration Date : 2026-12-12
US Patent Number : 9079912
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code : U-3227
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-12-12
Patent Expiration Date : 2031-11-20
US Patent Number : 11219624*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-11-20
Patent Expiration Date : 2026-12-12
US Patent Number : 9079912
Drug Substance Claim :
Drug Product Claim :
Application Number : 215309
Patent Use Code : U-3404
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-12-12
Patent Expiration Date : 2028-06-12
US Patent Number : 8829013
Drug Substance Claim :
Drug Product Claim :
Application Number : 202192
Patent Use Code : U-3228
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-06-12
ABOUT THIS PAGE
41
PharmaCompass offers a list of Ruxolitinib Phosphate 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 Ruxolitinib Phosphate manufacturer or Ruxolitinib Phosphate supplier for your needs.
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PharmaCompass also assists you with knowing the Ruxolitinib Phosphate API Price utilized in the formulation of products. Ruxolitinib Phosphate API Price is not always fixed or binding as the Ruxolitinib Phosphate Price is obtained through a variety of data sources. The Ruxolitinib Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ruxolitinib phosphate (JAN/USAN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ruxolitinib phosphate (JAN/USAN), including repackagers and relabelers. The FDA regulates Ruxolitinib phosphate (JAN/USAN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ruxolitinib phosphate (JAN/USAN) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Ruxolitinib phosphate (JAN/USAN) supplier is an individual or a company that provides Ruxolitinib phosphate (JAN/USAN) active pharmaceutical ingredient (API) or Ruxolitinib phosphate (JAN/USAN) finished formulations upon request. The Ruxolitinib phosphate (JAN/USAN) suppliers may include Ruxolitinib phosphate (JAN/USAN) API manufacturers, exporters, distributors and traders.
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A Ruxolitinib phosphate (JAN/USAN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Ruxolitinib phosphate (JAN/USAN) active pharmaceutical ingredient (API) in detail. Different forms of Ruxolitinib phosphate (JAN/USAN) DMFs exist exist since differing nations have different regulations, such as Ruxolitinib phosphate (JAN/USAN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ruxolitinib phosphate (JAN/USAN) DMF submitted to regulatory agencies in the US is known as a USDMF. Ruxolitinib phosphate (JAN/USAN) USDMF includes data on Ruxolitinib phosphate (JAN/USAN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ruxolitinib phosphate (JAN/USAN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 (JAN/USAN) Drug Master File in Korea (Ruxolitinib phosphate (JAN/USAN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ruxolitinib phosphate (JAN/USAN). The MFDS reviews the Ruxolitinib phosphate (JAN/USAN) KDMF as part of the drug registration process and uses the information provided in the Ruxolitinib phosphate (JAN/USAN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ruxolitinib phosphate (JAN/USAN) 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 (JAN/USAN) API can apply through the Korea Drug Master File (KDMF).
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A Ruxolitinib phosphate (JAN/USAN) written confirmation (Ruxolitinib phosphate (JAN/USAN) WC) is an official document issued by a regulatory agency to a Ruxolitinib phosphate (JAN/USAN) manufacturer, verifying that the manufacturing facility of a Ruxolitinib phosphate (JAN/USAN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ruxolitinib phosphate (JAN/USAN) APIs or Ruxolitinib phosphate (JAN/USAN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Ruxolitinib phosphate (JAN/USAN) WC (written confirmation) as part of the regulatory process.
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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 (JAN/USAN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ruxolitinib phosphate (JAN/USAN) API and other APIs are published in this directory by the FDA.
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 (JAN/USAN) 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.
The NDC directory also contains data on finished compounded human drug products that contain Ruxolitinib phosphate (JAN/USAN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ruxolitinib phosphate (JAN/USAN) NDC to their finished compounded human drug products, they may choose to do so.
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Ruxolitinib phosphate (JAN/USAN) 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 (JAN/USAN) 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 Ruxolitinib phosphate (JAN/USAN) GMP manufacturer or Ruxolitinib phosphate (JAN/USAN) GMP API supplier for your needs.
A Ruxolitinib phosphate (JAN/USAN) CoA (Certificate of Analysis) is a formal document that attests to Ruxolitinib phosphate (JAN/USAN)'s compliance with Ruxolitinib phosphate (JAN/USAN) specifications and serves as a tool for batch-level quality control.
Ruxolitinib phosphate (JAN/USAN) CoA mostly includes findings from lab analyses of a specific batch. For each Ruxolitinib phosphate (JAN/USAN) 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 (JAN/USAN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Ruxolitinib phosphate (JAN/USAN) EP), Ruxolitinib phosphate (JAN/USAN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ruxolitinib phosphate (JAN/USAN) USP).