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1. Cyclopenta(c)pyrrole-2(1h)-carboxamide, Hexahydro-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-, (3a Alpha,5 Alpha,6a Alpha)-
2. Ivarmacitinib Sulfate
3. Shr0302
4. Shr0302 Base
1. Shr0302
2. 1445987-21-2
3. Ivarmacitinib [usan]
4. Unii-k6k4b9z5tv
5. K6k4b9z5tv
6. (3as,6ar)-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]-3,3a,4,5,6,6a-hexahydro-1h-cyclopenta[c]pyrrole-2-carboxamide
7. Shr-0302
8. Shr0302 Base
9. Ivarmacitinib [inn]
10. Shr0302 Free Base
11. Shr-0302 Free Base
12. Schembl15077696
13. Schembl15077710
14. Schembl16191633
15. Gtpl11878
16. Ex-a5101
17. Who 11823
18. Ncgc00687790-01
19. Ac-36766
20. Example 34 [wo2013091539a1]
21. Hy-112724
22. Cs-0062969
23. Us9527851, 34
24. Us9527851, 74
25. (3ar,5s,6as)-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl (7h-pyrrolo(2,3- D)pyrimidin-4-yl)amino) Hexahydrocyclopenta(c)pyrrole-2(1h)-carboxamide
26. (3ar,5s,6as)-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl (7h-pyrrolo(2,3-d)pyrimidin-4-yl)amino) Hexahydrocyclopenta(c)pyrrole-2(1h)-carboxamide
27. (3ar,6as)-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-[methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino]-3,3a,4,5,6,6a-hexahydro-1h-cyclopenta[c]pyrrole-2-carboxamide
28. Cyclopenta(c)pyrrole-2(1h)-carboxamide, Hexahydro-n-(3-methoxy-1,2,4- Thiadiazol-5-yl)-5-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-, (3a.alpha.,5.alpha.,6a.alpha.)-
29. Cyclopenta(c)pyrrole-2(1h)-carboxamide, Hexahydro-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl-7h-pyrrolo(2,3-d)pyrimidin-4-ylamino)-, (3aalpha,5alpha,6aalpha)-
30. Rel-(3ar,5s,6as)-n-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl(7h-pyrrolo[2,3-d]pyrimidin-4-yl)amino)hexahydrocyclopenta[c]pyrrole-2(1h)-carboxamide
Molecular Weight | 414.5 g/mol |
---|---|
Molecular Formula | C18H22N8O2S |
XLogP3 | 2.3 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 4 |
Exact Mass | 414.15864315 g/mol |
Monoisotopic Mass | 414.15864315 g/mol |
Topological Polar Surface Area | 140 Ų |
Heavy Atom Count | 29 |
Formal Charge | 0 |
Complexity | 600 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33027
Submission : 2018-08-21
Status : Active
Type : II
ABOUT THIS PAGE
A Ivarmacitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivarmacitinib, including repackagers and relabelers. The FDA regulates Ivarmacitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivarmacitinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ivarmacitinib supplier is an individual or a company that provides Ivarmacitinib active pharmaceutical ingredient (API) or Ivarmacitinib finished formulations upon request. The Ivarmacitinib suppliers may include Ivarmacitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ivarmacitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ivarmacitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivarmacitinib active pharmaceutical ingredient (API) in detail. Different forms of Ivarmacitinib DMFs exist exist since differing nations have different regulations, such as Ivarmacitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivarmacitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ivarmacitinib USDMF includes data on Ivarmacitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivarmacitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivarmacitinib suppliers with USDMF on PharmaCompass.
Ivarmacitinib 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 Ivarmacitinib 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 Ivarmacitinib GMP manufacturer or Ivarmacitinib GMP API supplier for your needs.
A Ivarmacitinib CoA (Certificate of Analysis) is a formal document that attests to Ivarmacitinib's compliance with Ivarmacitinib specifications and serves as a tool for batch-level quality control.
Ivarmacitinib CoA mostly includes findings from lab analyses of a specific batch. For each Ivarmacitinib 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.
Ivarmacitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ivarmacitinib EP), Ivarmacitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ivarmacitinib USP).
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