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1. 6-amino-5-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-n-(4-(4-methylpiperazine-1-carbonyl)phenyl)pyridazine-3-carboxamide
2. Ensartinib
3. X-396
1. 1365267-27-1
2. X-376
3. X-396
4. 7dr7jmb8bh
5. Chembl2376648
6. 6-amino-5-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-n-[4-(4-methylpiperazine-1-carbonyl)phenyl]pyridazine-3-carboxamide
7. 3-pyridazinecarboxamide, 6-amino-5-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-n-(4-((4-methyl-1-piperazinyl)carbonyl)phenyl)-
8. Unii-7dr7jmb8bh
9. Gtpl8959
10. Schembl15131466
11. Bcp07190
12. Ex-a2227
13. Bdbm50432894
14. Nsc800968
15. S6505
16. Zinc96258164
17. Cs-6077
18. Db13104
19. Nsc-800968
20. Example 18 [wo2012048259]
21. Ac-35751
22. Hy-16590
23. X376
24. X 396
25. X-376; X-396
26. Q27077191
| Molecular Weight | 547.4 g/mol |
|---|---|
| Molecular Formula | C25H25Cl2FN6O3 |
| XLogP3 | 3.2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 6 |
| Exact Mass | 546.1349222 g/mol |
| Monoisotopic Mass | 546.1349222 g/mol |
| Topological Polar Surface Area | 114 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 784 |
| 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 | 1 |
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
Protein Kinase Inhibitors
Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)
API SUPPLIERS
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Listed Suppliers
About the Company : Hope Chem is dedicated to manufacturing, marketing, and CMO service of Active Pharmaceutical Ingredients (APIs), Intermediates, and Specialty Chemicals since the year 2010. Current...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Ensartinib
Therapeutic Area: Oncology Brand Name: X-396
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Accepts New Drug Application for Ensartinib
Details : X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
Brand Name : X-396
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 13, 2024
Details:
NMPA’s nod in China marked first ensartinib approval based on results of eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC.
Lead Product(s): Ensartinib
Therapeutic Area: Oncology Brand Name: X-396
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Betta Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Lead Product(s) : Ensartinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Betta Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC
Details : NMPA’s nod in China marked first ensartinib approval based on results of eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC.
Brand Name : X-396
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
ABOUT THIS PAGE
A Ensartinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ensartinib, including repackagers and relabelers. The FDA regulates Ensartinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ensartinib 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 Ensartinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ensartinib supplier is an individual or a company that provides Ensartinib active pharmaceutical ingredient (API) or Ensartinib finished formulations upon request. The Ensartinib suppliers may include Ensartinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ensartinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Ensartinib 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 Ensartinib 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 Ensartinib GMP manufacturer or Ensartinib GMP API supplier for your needs.
A Ensartinib CoA (Certificate of Analysis) is a formal document that attests to Ensartinib's compliance with Ensartinib specifications and serves as a tool for batch-level quality control.
Ensartinib CoA mostly includes findings from lab analyses of a specific batch. For each Ensartinib 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.
Ensartinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ensartinib EP), Ensartinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ensartinib USP).
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