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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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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

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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

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API Reference Price

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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705948200,"product":"ALECTINIB HYDROCHLORIDE IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"HANDA PHARMACEUTICALS INC","customerCountry":"TAIWAN","quantity":"0.32","actualQuantity":"0.32","unit":"KGS","unitRateFc":"25600","totalValueFC":"7914","currency":"USD","unitRateINR":2055459.4375,"date":"23-Jan-2024","totalValueINR":"657747.02","totalValueInUsd":"7914","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"6945894","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712255400,"product":"ALECTINIB HYDROCHLORIDE IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"TO THE ORDER OF","customerCountry":"TAIWAN","quantity":"0.18","actualQuantity":"0.18","unit":"KGS","unitRateFc":"25600","totalValueFC":"4500.3","currency":"USD","unitRateINR":2087804.4444444445,"date":"05-Apr-2024","totalValueINR":"375804.8","totalValueInUsd":"4500.3","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"8914614","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"ALECTINIB HYDROCHLORIDE IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"TO THE ORDER OF","customerCountry":"RUSSIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"26666.7","totalValueFC":"7839.9","currency":"USD","unitRateINR":2181563.3333333335,"date":"26-Jun-2024","totalValueINR":"654469","totalValueInUsd":"7839.9","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"1961909","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724265000,"product":"ALECTINIB HYDROCHLORIDE","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"KUKJEON PHARMACEUTICAL CO","customerCountry":"REPUBLIC OF KOREA","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"15000","totalValueFC":"2154","currency":"USD","unitRateINR":1204500,"date":"22-Aug-2024","totalValueINR":"180675","totalValueInUsd":"2154","indian_port":"Hyderabad Air","hs_no":"29331999","bill_no":"3409612","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726252200,"product":"ALECTINIB HYDROCHLORIDE. BATCH NO. 104202-01-00003. MFG. 20.01.2024 RETEST 19.01.2026","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"PORTON PHARMA SOLUTIONS","supplierCountry":"CHINA","foreign_port":"CHONGQING","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"11000","totalValueFC":"531.9","currency":"USD","unitRateINR":"1782900","date":"14-Sep-2024","totalValueINR":"44572.5","totalValueInUsd":"531.9","indian_port":"Ahmedabad Air","hs_no":"29333990","bill_no":"5604847","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHONGQING","supplierAddress":"1 Fine Chemical Zone, Chongqing Che mical Industry Park, Changshou,Chon gqing,401221 CHINA Chongqing, , CHI CHINA","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"}]

Number of Transactions

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ALECTINIB HYDROCHLORIDE

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ABOUT THIS PAGE

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ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

17 API Suppliers

6 USDMF

2 EU WC

5 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

INTERMEDIATES

12 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

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

EXCIPIENTS BY APPLICATIONS

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