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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 6 USDMF, 2 EU WC, 5 NDC API, 13 Listed Suppliers

16 API Suppliers
6 USDMF
2 EU WC
5 NDC API
13 Listed Suppliers

DEVELOPMENTS

12 Drugs in Development

12 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

EXCIPIENTS BY APPLICATIONS

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 41 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
41 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

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

MARKET PLACE

4 APIs

marketPlace
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

KDMF

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

12DRUGS 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

01

Porton Pharma Solutions

China

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

Cosmoprof India

Not Confirmed

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

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China

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

02

Egis Pharmaceuticals PLC

Hungary

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

Cosmoprof India

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Hungary

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

03

Shandong Chenghui Shuangda Pharmac...

China

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

CPhI China

Attending

Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

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China

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

Shandong Chenghui Shuangda Pharmaceutical

Product Web Link

04

Sichuan Elixir Pharmaceuticals

China

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

Cosmoprof India

Not Confirmed

Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..

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China

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

05

MSN Laboratories

India

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

Cosmoprof India

Not Confirmed

Not Confirmed

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USDMF

01

Porton Pharma Solutions Ltd

China

DDL Conference

Not Confirmed

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

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China

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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

DDL Conference

Not Confirmed

03

Hetero Labs Ltd

India

DDL Conference

Not Confirmed

04

Msn Laboratories Private Ltd

India

DDL Conference

Not Confirmed

05

Natco Pharma Ltd

India

DDL Conference

Not Confirmed

06

Sun Pharmaceutical Industries Ltd

India

DDL Conference

Not Confirmed

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EU WC

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NDC API

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Listed Suppliers

01

Porton Pharma Solutions

China

Antibody Engineering

Not Confirmed

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

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China

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Alectinib Hydrochloride

About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...

Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities are located in China, Slovenia, the US, Belgium, Switzerland, Denmark, with more than 6000 employees worldwide. Porton leads the way with its excellent CDMO services, but also supplies APIs & intermediates for the treatment of critical diseases such as HIV/AIDS, diabetes, cancer, & influenza. Our Process Technology Centers & WHO/USFDA/EMA/PDMA/NMPA-inspected Facilities feature state-of-the-art equipment, highly flexible cGMP-compliant production assets.

02

Egis Pharmaceuticals PLC

Hungary

Antibody Engineering

Not Confirmed

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Hungary

Virtual Booth

Digital Content

Alectinib Hydrochloride

About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...

Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.

03

Shandong Chenghui Shuangda Pharmace...

China

CPhI China

Attending

Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.

Contact Supplier

China

Virtual Booth

Digital Content

Alectinib Hydrochloride

About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...

Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has 6 workshops and 9 production lines which has 100t/month production capacity.The company is committed to maintain the standards with continuous improvements to the current standards throughout the product lifecycle.The main products include local anesthetic drugs, antiviral drugs, cardiovascular and cerebrovascular drugs, antitumor drugs, gastrointestinal drugs, diabetic drugs, veterinary drugs, and CDMO products.

Product Web Link

04

Sichuan Elixir Pharmaceuticals

China

Antibody Engineering

Not Confirmed

Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..

Contact Supplier

China

Virtual Booth

Digital Content

Alectinib Hydrochloride

About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...

Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ANDA, 505b(2) and P-IV challenges. Exploring macromolecular APIs, we focus on Glycans & polypeptides. Expertise in XDC drugs drives innovative research & payload production. With a global registration platform & international cGMP system, we offer API CMO/CDMO services worldwide. Our strategy combines FDF and APIs. Our labs meet GMP standards with a stable R&D team, over 10 years of experience, we've delivered 20+ successful projects.