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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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RLD :
TE Code :
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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RLD :
TE Code :
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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RLD :
TE Code :
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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RLD : Yes
TE Code :
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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RLD : Yes
TE Code :
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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RLD : Yes
TE Code :
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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RLD : Yes
TE Code :
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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RLD : Yes
TE Code :
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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RLD : Yes
TE Code :
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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RLD :
TE Code :
Brand Name : RUXOLITINIB
Dosage Form : TABLET
Dosage Strength : 10MG
Approval Date :
Application Number : 220375
RX/OTC/DISCN :
RLD :
TE Code :

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Regulatory Info : Allowed
Registration Country : Switzerland
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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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Jakavi
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Denmark
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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Regulatory Info : Approved
Registration Country : Sweden
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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Regulatory Info : Approved
Registration Country : Sweden
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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Regulatory Info : Approved
Registration Country : Sweden
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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Regulatory Info : PRESCRIPTION
Registration Country : Canada
RUXOLITINIB (RUXOLITINIB PHOSPHATE)
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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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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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Regulatory Info : PRESCRIPTION
Registration Country : Canada
RUXOLITINIB (RUXOLITINIB PHOSPHATE)
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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Regulatory Info : PRESCRIPTION
Registration Country : Canada
RUXOLITINIB (RUXOLITINIB PHOSPHATE)
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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Regulatory Info : PRESCRIPTION
Registration Country : Canada
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
Brand Name : Jakavi
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
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Registration Country : Australia

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Registration Country : Australia
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Packaging : 56
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Application Number :
Regulatory Info :
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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Registration Country : Australia
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Packaging : 56
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Registration Country : Australia

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Registration Country : Australia
Brand Name : Jakavi
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Packaging : 56
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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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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

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Jakavi 15 mg
Dosage Form : TAB
Dosage Strength : 15mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Jakavi 5 mg
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
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ABOUT THIS PAGE
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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.
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.
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.
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.
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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 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).
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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.
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).
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.
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.
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 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.
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).