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17 API Suppliers, 6 USDMF, 2 EU WC, 5 NDC API, 14 Listed Suppliers, $ API Reference Price

17 API Suppliers
6 USDMF
2 EU WC
5 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

INTERMEDIATES

12 Intermediates Suppliers

12 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

5 FDF Dossiers, 1 FDA Orange Book, 1 Europe, 1 Canada, 1 Australia, 1 South Africa

5 FDF Dossiers
1 FDA Orange Book
1 Europe
1 Canada
1 Australia
1 South Africa

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 3 SPI Pharma, 5 DKSH, 5 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 5 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 3 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 26 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 1 Novo Excipients, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 8 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

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45 Coating Systems & Additives, 42 Fillers, Diluents & Binders, 19 Controlled & Modified Release, 17 Direct Compression, 10 Granulation, 10 Lubricants & Glidants, 9 Co-Processed Excipients, 8 Thickeners and Stabilizers, 7 Taste Masking, 7 Film Formers & Plasticizers, 6 Disintegrants & Superdisintegrants, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Rheology Modifiers, 4 Chewable & Orodispersible Aids, 3 API Stability Enhancers, 3 Emulsifying Agents, 3 Parenteral, 1 Surfactant & Foaming Agents, 1 Solubilizers, 1 Topical, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Finished Drug Prices, 7 Annual Reports

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1 US Medicaid Prescriptions
1 Finished Drug Prices
7 Annual Reports

MARKET PLACE

4 APIs

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4 APIs

PATENTS & EXCLUSIVITIES

5 US Patents, 3 US Exclusivities

patents
5 US Patents
3 US Exclusivities

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

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NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 13,993

MARKET PLACE

API

FDF

12INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

11DRUGS IN DEVELOPMENT

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)

153,932,232

Annual Reports (USD Million)

8,077

Finished Drug Prices

133 RELATED EXCIPIENT COMPANIES

214EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 1256589-74-8, Af-802 hydrochloride, Alectinib hcl, Alecensa, P9yy73lo6j, Alectinib hydrochloride (jan)

Molecular Formula

C₃₀H₃₅ClN₄O₂

Molecular Weight

519.1 g/mol

InChI Key

GYABBVHSRIHYJR-UHFFFAOYSA-N

FDA UNII

P9YY73LO6J

1 2D Structure

Alectinib Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5H-benzo[b]carbazole-3-carbonitrile;hydrochloride

2.1.2 InChI

InChI=1S/C30H34N4O2.ClH/c1-4-20-16-23-24(17-26(20)34-9-7-21(8-10-34)33-11-13-36-14-12-33)30(2,3)29-27(28(23)35)22-6-5-19(18-31)15-25(22)32-29;/h5-6,15-17,21,32H,4,7-14H2,1-3H3;1H

2.1.3 InChI Key

GYABBVHSRIHYJR-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCC1=CC2=C(C=C1N3CCC(CC3)N4CCOCC4)C(C5=C(C2=O)C6=C(N5)C=C(C=C6)C#N)(C)C.Cl

2.2 Other Identifiers

2.2.1 UNII

P9YY73LO6J

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Alecensa

2. Alectinib

3. Ch5424802

4. Ro5424802

2.3.2 Depositor-Supplied Synonyms

1. 1256589-74-8

2. Af-802 Hydrochloride

3. Alectinib Hcl

4. Alecensa

5. P9yy73lo6j

6. Alectinib Hydrochloride (jan)

7. Alectinib (hydrochloride)

8. Ch5424802 (hydrochloride)

9. Schembl14991271

10. 5h-benzo[b]carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-, Hydrochloride (1:1)

11. Alectinib Hydrochloride [jan]

12. 9-ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5h-benzo[b]carbazole-3-carbonitrile Hydrochloride

13. Unii-p9yy73lo6j

14. Alecensa (tn)

15. 5h-benzo(b)carbazole-3-carbonitrile, 9-ethyl-6,11-dihydro-6,6-dimethyl-8-(4-(4-morpholinyl)-1-piperidinyl)-11-oxo-, Hydrochloride (1:1)

16. Alectinib Monohydrochloride

17. Af-802 (hydrochloride)

18. Agn-pc-09o9bf

19. Ro5424802 (hydrochloride)

20. Chembl3707320

21. Chebi:62268

22. Ch5424802 Hcl

23. Dtxsid10154841

24. Ch 5424802, Alectinib Hcl

25. Bcp09075

26. Ex-a1553

27. Alectinib Hydrochloride [mi]

28. Ch-5424802 Hydrochloride

29. Hy-13011a

30. Mfcd27987893

31. S5232

32. Ccg-264759

33. Cs-3480

34. Sb16516

35. Alectinib Hydrochloride [who-dd]

36. 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5h-benzo[b]carbazole-3-carbonitrile,hydrochloride

37. Ac-29721

38. As-17062

39. Alectinib Hydrochloride [orange Book]

40. D10450

41. Q27104897

42. Ch5424802 Hcl Salt, Alectinib Hcl Salt, Af802 Hcl Salt

43. Ch-5428402 Hcl; Af-802 Hydrochloride; Rg-7853 Hydrochloride; Ro-5424802 Hydrochloride

44. 9-ethyl-6,11-dihydro-6,6-dimethyl-8-[4-(4-morpholinyl)-1-piperidinyl]-11-oxo-5h-benzo[b]carbazole-3-carbonitrile Hydrochloride (1:1)

45. 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5h-benzo[b]carbazole-3-carbonitrile Monohydrochloride Salt

46. 9-ethyl-6,6-dimethyl-8-(4-morpholin-4-ylpiperidin-1-yl)-11-oxo-5h-benzo[b]carbazole-3-carbonitrile;hydrochloride

47. Alectinib Hydrochloride;af-802 Hydrochloride;ch-5424802 Hydrochloride;rg-7853 Hydrochloride;ro-5424802 Hydrochloride

2.3.3 Other Synonyms

1. Alectinib

2. 1256580-46-7

3. Arq-761

4. Cas 1416163-60-4

5. Cas 1256580-46-7

2.4 Create Date

2011-07-05

3 Chemical and Physical Properties

Molecular Formula	C₃₀H₃₅ClN₄O₂
Molecular Weight	519.1 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	3
Exact Mass	518.2448541 g/mol
Monoisotopic Mass	518.2448541 g/mol
Topological Polar Surface Area	72.4 Å²
Heavy Atom Count	37
Formal Charge	0
Complexity	867
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	2

4 Drug and Medication Information

4.1 Drug Indication

Alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Alecensa as monotherapy is indicated for the treatment of adult patients with ALKpositive advanced NSCLC previously treated with crizotinib.

5 Pharmacology and Biochemistry

5.1 FDA Pharmacological Classification

5.1.1 Pharmacological Classes

Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]

5.2 ATC Code

L01ED03

API SUPPLIERS

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USDMF

01

Porton Pharma Solutions Ltd

China

The Pharmacy Technology

Not Confirmed

Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

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China

Virtual Booth

Digital Content

Alectinib Hydrochloride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40093

Submission : 2024-06-13

Status : Active

Type : II

02

Fresenius Kabi Oncology Ltd

India

The Pharmacy Technology

Not Confirmed

Not Confirmed

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EU WC

01

Fresenius Kabi Oncology Limited

India

Compamed

Not Confirmed

02

MSN Laboratories

India

Compamed

Not Confirmed

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NDC API

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Listed Suppliers

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API Reference Price

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