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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 8 USDMF, 6 EU WC, 4 NDC API, 22 Listed Suppliers, $ API Reference Price

27 API Suppliers
8 USDMF
6 EU WC
4 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

29 Intermediates Suppliers

29 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 6 FDA Orange Book, 15 Europe, 3 Canada, 8 Australia, 3 South Africa

35 FDF Dossiers
6 FDA Orange Book
15 Europe
3 Canada
8 Australia
3 South Africa

DIGITAL CONTENT

29 NEWS #PharmaBuzz

media
29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 11 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
11 Finished Drug Prices

MARKET PLACE

6 APIs, 1 FDF Dossiers

marketPlace
6 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

30 US Patents, 12 US Exclusivities

patents
30 US Patents
12 US Exclusivities

REF. STANDARDS & IMPURITIES

7 Others

otherSolutions
7 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

44,799,472

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 850140-73-7, Afatinib (dimaleate), Gilotrif, Afatinib maleate, Bibw 2992ma2, Giotrif

Molecular Formula

C₃₂H₃₃ClFN₅O₁₁

Molecular Weight

718.1 g/mol

InChI Key

USNRYVNRPYXCSP-JUGPPOIOSA-N

FDA UNII

V1T5K7RZ0B

A quinazoline and butenamide derivative that acts as a tyrosine kinase inhibitor of epidermal growth factor receptors (ERBB RECEPTORS) and is used in the treatment of metastatic NON-SMALL CELL LUNG CANCER.

1 2D Structure

Afatinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(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

2.1.2 InChI

InChI=1S/C24H25ClFN5O3.2C4H4O4/c1-31(2)8-3-4-23(32)30-21-11-17-20(12-22(21)34-16-7-9-33-13-16)27-14-28-24(17)29-15-5-6-19(26)18(25)10-15;2*5-3(6)1-2-4(7)8/h3-6,10-12,14,16H,7-9,13H2,1-2H3,(H,30,32)(H,27,28,29);2*1-2H,(H,5,6)(H,7,8)/b4-3+;2*2-1-/t16-;;/m0../s1

2.1.3 InChI Key

USNRYVNRPYXCSP-JUGPPOIOSA-N

2.1.4 Canonical SMILES

CN(C)CC=CC(=O)NC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC(=C(C=C3)F)Cl)OC4CCOC4.C(=CC(=O)O)C(=O)O.C(=CC(=O)O)C(=O)O

2.1.5 Isomeric SMILES

CN(C/C=C/C(=O)NC1=C(C=C2N=CN=C(C2=C1)NC3=CC(=C(C=C3)F)Cl)O[C@@H]4COCC4)C.C(=C\C(=O)O)\C(=O)O.C(=C\C(=O)O)\C(=O)O

2.2 Other Identifiers

2.2.1 UNII

V1T5K7RZ0B

2.3 Synonyms

2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date

2007-02-12

3 Chemical and Physical Properties

Molecular Formula	C₃₂H₃₃ClFN₅O₁₁
Molecular Weight	718.1 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Indication

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.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

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.)

5.2 ATC Code

L01XE13

API SUPPLIERS

01

LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

TAPI Technology & API Services

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

Contact Supplier

Israel

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Corporate PDF

03

Alembic Pharmaceuticals Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024

Not Confirmed

Not Confirmed

10

Shilpa Medicare

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

AES 2024

Not Confirmed

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Listed Suppliers

01

LGM Pharma

U.S.A

AES 2024

Not Confirmed

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

Afatinib

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.

02

TAPI Technology & API Services

Israel

CPhI WW Frankfurt

Booth #6.1A32

TAPI offers customized CDMO Solutions for API development and manufacturing services.

Contact Supplier

Israel

Virtual Booth

Digital Content

Afatinib

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.

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