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1. 2-fluoro-4-(7-((quinolin-6-yl)methyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzoic Acid
2. 2-fluoro-4-(7-((quinolin-6-yl)methyl)imidazo(1,2-b)-(1,2,4)triazin-2-yl)benzamide
3. 2-fluoro-n-methyl-4-(7-((quinolin-6-yl)methyl)imidazo(1,2- B)(1,2,4)triazin-2-yl)benzamide Dihydrochloride Monohydrate
4. 2-fluoro-n-methyl-4-(7-(quinolin-6-yl-methyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide
5. 2-fluoro-n-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide
6. 2-fluoro-n-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide Dihydrochloride
7. Capmatinib
8. Capmatinib Dihydrochloride
9. Capmatinib Dihydrochloride Monohydrate
10. Capmatinib Hydrochloride Anhydrous
11. Capmatinib Metabolite M13
12. Capmatinib Metabolite M18
13. Cmc-583
14. Cmc583
15. Cnj-294
16. Cnj294
17. Inc-280
18. Inc280
19. Incb-28060
20. Incb-28060 Free Base
21. Incb28060
22. Nvp-inc280
23. Nvp-inc280-nx
24. Tabrecta
1. 1865733-40-9
2. Nvp-inc280-aaa
3. Capmatinib Hydrochloride [usan]
4. C2a374o70x
5. Capmatinib (dihydrochloride Hydrate)
6. Tabrecta
7. Capmatinib Dihydrochloride Monohydrate
8. Capmatinib Hydrochloride (usan)
9. Capmatinib Hydrochloride Hydrate (jan)
10. 2-fluoro-n-methyl-4-(7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl)benzamide Dihydrochloride Hydrate
11. Capmatinib Hydrochloride Hydrate [jan]
12. Tabrecta (tn)
13. Capmatinib 2hcl.h2o
14. Capmatinib 2hcl Hydrate
15. Inc-280 Hydrochloride
16. Incb28060 Hydrochloride
17. Unii-c2a374o70x
18. Capmatinib Hydrochloride Hydrate
19. Chembl3989937
20. Dtxsid401027869
21. Hy-13404c
22. Capmatinib Hydrochloride [who-dd]
23. Capmatinib Hydrochloride Monohydrate
24. Cs-0198834
25. Capmatinib Hydrochloride [orange Book]
26. D10891
27. Q27895918
28. 2-fluoro-n-methyl-4-(7-((quinolin-6-yl)methyl)imidazo(1,2- B)(1,2,4)triazin-2-yl)benzamide Dihydrochloride Monohydrate
29. Benzamide, 2-fluoro-n-methyl-4-(7-(6-quinolinylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)-, Hydrochloride, Hydrate (1:2:1)
| Molecular Weight | 503.4 g/mol |
|---|---|
| Molecular Formula | C23H21Cl2FN6O2 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 4 |
| Exact Mass | 502.1087075 g/mol |
| Monoisotopic Mass | 502.1087075 g/mol |
| Topological Polar Surface Area | 86.1 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 637 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 4 |
Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.
L01EX17
NDC Package Code : 76047-002
Start Marketing Date : 2023-09-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 50384-6500
Start Marketing Date : 2023-07-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (90kg/90kg)
Marketing Category : BULK INGREDIENT

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Tabrecta is a kinase inhibitor that targets MET. European Commission approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy.
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 22, 2022

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Receives European Commission Approval for Tabrecta® for the Treatment of METex14 Skippin...
Details : Tabrecta is a kinase inhibitor that targets MET. European Commission approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition f...
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 22, 2022

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Opinion based on Phase II GEOMETRY mono-1 study for Tabrecta showing an overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with advanced NSCLC harboring alterations leading to MET exon 14 skipping.
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Incyte Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2022

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Incyte Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Receives Positive CHMP Opinion for Tabrecta® for Patients with METex14 Advanced Non-Smal...
Details : Opinion based on Phase II GEOMETRY mono-1 study for Tabrecta showing an overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with advanced NSCLC harboring alterations leading to MET ex...
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2022

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Positive opinion for Tabrecta from CHMP based on Phase 2 GEOMETRY mono-1 study showing overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with NSCLC harboring alterations leading to MET exon 14 skipping.
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2022

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Incyte Announces Positive CHMP Opinion for Capmatinib (Tabrecta®) for the Treatment of METex14 Ad...
Details : Positive opinion for Tabrecta from CHMP based on Phase 2 GEOMETRY mono-1 study showing overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with NSCLC harboring alterations leading to ...
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 22, 2022

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TABRECTA® is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14.
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 15, 2021

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be Used as a Companion Dia...
Details : TABRECTA® is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14.
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 15, 2021

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The New England Journal of Medicine show treatment with Tabrecta™ resulted in positive overall response rates (ORR) among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to skipping of MET exon 14 (METex14).
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 02, 2020

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Announces Nejm Publication of Pivotal Study of Tabrecta™ in Patients with ME Tex14 Meta...
Details : The New England Journal of Medicine show treatment with Tabrecta™ resulted in positive overall response rates (ORR) among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to skipping of MET exon ...
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 02, 2020

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Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METex14) respectively.
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 29, 2020

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Announces MET Inhibitor Tabrecta™ Approved in Japan for Advanced Non-Small Cell Lung Ca...
Details : Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METex14) respectively.
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 29, 2020

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Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer. There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC.
Lead Product(s): Capmatinib Hydrochloride,Inapplicable
Therapeutic Area: Oncology Brand Name: Tabrecta
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 11, 2020

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Lead Product(s) : Capmatinib Hydrochloride,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer. There are currently no approved therapies that specifically target METex1...
Product Name : Tabrecta
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 11, 2020

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PharmaCompass offers a list of Capmatinib Hydrochloride 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 Capmatinib Hydrochloride manufacturer or Capmatinib Hydrochloride supplier for your needs.
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A Capmatinib Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Capmatinib Hydrochloride, including repackagers and relabelers. The FDA regulates Capmatinib Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Capmatinib Hydrochloride 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 Capmatinib Hydrochloride supplier is an individual or a company that provides Capmatinib Hydrochloride active pharmaceutical ingredient (API) or Capmatinib Hydrochloride finished formulations upon request. The Capmatinib Hydrochloride suppliers may include Capmatinib Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Capmatinib Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Capmatinib Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Capmatinib Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Capmatinib Hydrochloride DMFs exist exist since differing nations have different regulations, such as Capmatinib Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Capmatinib Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Capmatinib Hydrochloride USDMF includes data on Capmatinib Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Capmatinib Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Capmatinib Hydrochloride suppliers with USDMF 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 Capmatinib Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Capmatinib Hydrochloride 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 Capmatinib Hydrochloride 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 Capmatinib Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Capmatinib Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Capmatinib Hydrochloride suppliers with NDC on PharmaCompass.
Capmatinib Hydrochloride 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 Capmatinib Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Capmatinib Hydrochloride GMP manufacturer or Capmatinib Hydrochloride GMP API supplier for your needs.
A Capmatinib Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Capmatinib Hydrochloride's compliance with Capmatinib Hydrochloride specifications and serves as a tool for batch-level quality control.
Capmatinib Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Capmatinib Hydrochloride 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.
Capmatinib Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Capmatinib Hydrochloride EP), Capmatinib Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Capmatinib Hydrochloride USP).