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1. 11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,26-triazatetracyclo(19.3.1.1(2,6).1(8,12))heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene
2. Sb 1518
3. Sb-1518
4. Sb1518
1. 937272-79-2
2. Pacritinib (sb1518)
3. Sb1518
4. Sb-1518
5. Pacritinib(sb1518)
6. Onx-0803
7. Sb 1518
8. G22n65il3o
9. Vonjo
10. 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene
11. 14,19-dioxa-5,7,27-triazatetracyclo(19.3.1.12,6.18,12)heptacosa-1(25),2,4,6(27),8,10,12(26),16,21,23-decaene, 11-(2-(1-pyrrolidinyl)ethoxy)-, (16e)-
12. Chembl2181330
13. Pacritinib [inn]
14. Pacritinib (usan/inn)
15. Pacritinib [usan:inn]
16. Pacritinib [usan]
17. Pacritinib [who-dd]
18. Sb-1518 Tfa Salt
19. Unii-g22n65il3o
20. Gtpl7793
21. Schembl1108221
22. Chembl2035187
23. Schembl22819303
24. Ex-a240
25. Dtxsid801045679
26. Amy23364
27. Bax 2201
28. Bcp09091
29. Onx 0803
30. Bdbm50210177
31. Bdbm50400312
32. Mfcd22572772
33. Nsc759674
34. Nsc781626
35. S8057
36. Akos037515687
37. Ccg-269464
38. Cs-1741
39. Db11697
40. Nsc-759674
41. Nsc-781626
42. Ncgc00381564-02
43. Ncgc00390623-02
44. Ac-30280
45. As-35036
46. Hy-16379
47. Sw219864-1
48. D11768
49. Sb1518;sb-1518;sb 1518
50. Q3888693
51. (16e)-11-(2-pyrrolidin-1-ylethoxy)-14,19-dioxa-5,7,27-triazatetracyclo[19.3.1.12,6.18,12]heptacosa-1(24),2(27),3,5,8(26),9,11,16,21(25),22-decaene
| Molecular Weight | 472.6 g/mol |
|---|---|
| Molecular Formula | C28H32N4O3 |
| XLogP3 | 3.8 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 4 |
| Exact Mass | 472.24744090 g/mol |
| Monoisotopic Mass | 472.24744090 g/mol |
| Topological Polar Surface Area | 68.7 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 644 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Treatment of post-essential thrombocythaemia myelofibrosis, Treatment of post-polycythaemia vera myelofibrosis
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01E - Protein kinase inhibitors
L01EJ - Janus-associated kinase (jak) inhibitors
L01EJ03 - Pacritinib
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-10-17
Pay. Date : 2025-01-17
DMF Number : 41513
Submission : 2025-09-07
Status : Active
Type : II


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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
About the Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and...

About the Company : Wuhan Sun-shine chemical Corporation Limited (Shanghai Sun-shine Chemical Technology Corporation Limited) is a high-tech enterprise engaged inR&D and sales of related compounds of ...

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Regulatory Info : RX
Registration Country : USA
Brand Name : VONJO
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 100MG BASE
Packaging :
Approval Date : 2022-02-28
Application Number : 208712
Regulatory Info : RX
Registration Country : USA

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Patents & EXCLUSIVITIES
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Exclusivity Code : NCE
Exclusivity Expiration Date : 2027-02-28
Application Number : 208712
Product Number : 1
Exclusivity Details :

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Exclusivity Code : ODE-397
Exclusivity Expiration Date : 2029-02-28
Application Number : 208712
Product Number : 1
Exclusivity Details :

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69
PharmaCompass offers a list of Pacritinib 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 Pacritinib manufacturer or Pacritinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pacritinib manufacturer or Pacritinib supplier.
A Pacritinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pacritinib, including repackagers and relabelers. The FDA regulates Pacritinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pacritinib 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 Pacritinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Pacritinib supplier is an individual or a company that provides Pacritinib active pharmaceutical ingredient (API) or Pacritinib finished formulations upon request. The Pacritinib suppliers may include Pacritinib API manufacturers, exporters, distributors and traders.
click here to find a list of Pacritinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Pacritinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Pacritinib active pharmaceutical ingredient (API) in detail. Different forms of Pacritinib DMFs exist exist since differing nations have different regulations, such as Pacritinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pacritinib DMF submitted to regulatory agencies in the US is known as a USDMF. Pacritinib USDMF includes data on Pacritinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pacritinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
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Pacritinib 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 Pacritinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pacritinib GMP manufacturer or Pacritinib GMP API supplier for your needs.
A Pacritinib CoA (Certificate of Analysis) is a formal document that attests to Pacritinib's compliance with Pacritinib specifications and serves as a tool for batch-level quality control.
Pacritinib CoA mostly includes findings from lab analyses of a specific batch. For each Pacritinib 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.
Pacritinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Pacritinib EP), Pacritinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pacritinib USP).