Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
KDMF
0
VMF
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Annual Reports
NA
1. (2e)-n-(4-(3-chloro-4-fluoroanilino)-7-(((3s)-oxolan-3-yl)oxy)quinoxazolin-6-yl)-4-(dimethylamino)but-2-enamide
2. Afatinib
3. Afatinib Maleate
4. Bibw 2992
5. Bibw 2992 Ma2
6. Bibw 2992ma2
7. Bibw-2992
8. Bibw-2992-ma2
9. Bibw-2992ma2
10. Bibw2992
11. Bibw2992 Ma2
12. Gilotrif
1. 850140-73-7
2. Afatinib (dimaleate)
3. Gilotrif
4. Afatinib Maleate
5. Bibw 2992ma2
6. Giotrif
7. Afatinib (bibw2992) Dimaleate
8. Afatinib Dimaleate [usan]
9. Bibw2992 Ma2
10. Afatinib Maleate (jan)
11. V1t5k7rz0b
12. Bibw-2992ma2
13. Bibw2992-ma2
14. Bibw-2992 Ma2
15. Bibw-2992-ma2
16. Chebi:76003
17. 850140-73-7 (dimaleate)
18. Bibw2992 Dimaleate
19. Afatinib Dimaleate (usan)
20. (s,e)-n-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)but-2-enamide Dimaleate
21. Afatinib Maleate [jan]
22. Afatinib Impurity F
23. (2e)-n-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3s)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide Bis(hydrogen (2z)-but-2-enedioate)
24. (z)-but-2-enedioic Acid;(e)-n-[4-(3-chloro-4-fluoroanilino)-7-[(3s)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide
25. Unii-v1t5k7rz0b
26. Mfcd25974239
27. Gilotrif (tn)
28. Giotrif (tn)
29. Bibw2993 Dimaleate
30. Amy499
31. Afatinib Dimaleate [mi]
32. Chembl2105712
33. Afatinib Dimaleate [vandf]
34. Dtxsid701027713
35. Afatinib Dimaleate [who-dd]
36. Hy-10261a
37. S7810
38. Akos025401819
39. Ccg-270401
40. Cs-1329
41. Afatinib Dimaleate [orange Book]
42. Ac-26080
43. As-56967
44. Ba162012
45. D09733
46. Q27145677
47. (2e)-n-(4-[(3-chloro-4-fluorophenyl)amino]-7-{[(3s)-tetrahydrofuran-3-yl]oxy}quinazolin-6-yl)-4-(dimethylamino)but-2-enamide
48. (2e)-n-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3s)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-2-butenamide Dimaleate
49. (2e)-n-{4-[(3-chloro-4-fluorophenyl)amino]-7-[(3s)-tetrahydrofuran-3-yloxy]quinazolin-6-yl}-4-(dimethylamino)but-2-enamide Di[(2z)-but-2-enedioate]
50. (e)-4-dimethylamino-but-2-enoic Acid-(4-(3-chloro-4-fluoro-phenylamino)-7-((s)-tetra-hydrofuran-3-yloxy)-quinazolin-6yl)-amide Dimaleate
51. 2-butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3s)-tetrahydro-3-furanyl)oxy)- 6-quinazolinyl)-4-(dimethylamino)-, (2e)-, (2z)-2-butenedioate (1:2)
52. 2-butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3s)-tetrahydro-3-furanyl)oxy)-6-quinazolinyl)-4-(dimethylamino)-, (2e)-, (2z)-2-butenedioate (1:2)
53. 936631-70-8
Molecular Weight | 718.1 g/mol |
---|---|
Molecular Formula | C32H33ClFN5O11 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 12 |
Exact Mass | 717.1849127 g/mol |
Monoisotopic Mass | 717.1849127 g/mol |
Topological Polar Surface Area | 238 Ų |
Heavy Atom Count | 50 |
Formal Charge | 0 |
Complexity | 821 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 3 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
Giotrif as monotherapy is indicated for the treatment of
- Epidermal Growth Factor Receptor (EGFR) TKI-nave adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
- locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
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.)
L01XE13
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
Upgrade, download data, analyse, strategize, subscribe with us
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Afatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afatinib, including repackagers and relabelers. The FDA regulates Afatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afatinib 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 Afatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Afatinib supplier is an individual or a company that provides Afatinib active pharmaceutical ingredient (API) or Afatinib finished formulations upon request. The Afatinib suppliers may include Afatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Afatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Afatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Afatinib active pharmaceutical ingredient (API) in detail. Different forms of Afatinib DMFs exist exist since differing nations have different regulations, such as Afatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Afatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Afatinib USDMF includes data on Afatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Afatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Afatinib suppliers with USDMF on PharmaCompass.
A Afatinib written confirmation (Afatinib WC) is an official document issued by a regulatory agency to a Afatinib manufacturer, verifying that the manufacturing facility of a Afatinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Afatinib APIs or Afatinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Afatinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Afatinib 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 Afatinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Afatinib 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 Afatinib 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 Afatinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Afatinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Afatinib suppliers with NDC on PharmaCompass.
Afatinib 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 Afatinib 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 Afatinib GMP manufacturer or Afatinib GMP API supplier for your needs.
A Afatinib CoA (Certificate of Analysis) is a formal document that attests to Afatinib's compliance with Afatinib specifications and serves as a tool for batch-level quality control.
Afatinib CoA mostly includes findings from lab analyses of a specific batch. For each Afatinib 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.
Afatinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Afatinib EP), Afatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Afatinib USP).
LOOKING FOR A SUPPLIER?