DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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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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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 1 EU WC, 1 NDC API, 15 Listed Suppliers, $ API Reference Price

16 API Suppliers
1 EU WC
1 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

18 FDF Dossiers, 4 FDA Orange Book, 6 Europe, 8 Australia

18 FDF Dossiers
4 FDA Orange Book
6 Europe
8 Australia

RELATED EXCIPIENT COMPANIES

2 DKSH, 2 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 DFE Pharma, 1 Gangwal Chemicals, 14 Kerry, 7 Microlex e.U, 2 Pluviaendo, 1 Prachin Chemical, 2 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 1 Vasa Pharmachem

relatedExcipients
2 DKSH
2 Faran Shimi Pharmaceutical
4 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 DFE Pharma
1 Gangwal Chemicals
14 Kerry
7 Microlex e.U
2 Pluviaendo
1 Prachin Chemical
2 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Sigachi Industries
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

25 Fillers, Diluents & Binders, 8 Lubricants & Glidants, 8 Direct Compression, 5 Coating Systems & Additives, 5 Co-Processed Excipients, 4 Granulation, 2 Film Formers & Plasticizers, 2 Coloring Agents, 1 Emulsifying Agents, 1 Controlled & Modified Release, 1 Thickeners and Stabilizers, 1 Parenteral, 1 Taste Masking

excipientsByApplications
25 Fillers, Diluents & Binders
8 Lubricants & Glidants
8 Direct Compression
5 Coating Systems & Additives
5 Co-Processed Excipients
4 Granulation
2 Film Formers & Plasticizers
2 Coloring Agents
1 Emulsifying Agents
1 Controlled & Modified Release
1 Thickeners and Stabilizers
1 Parenteral
1 Taste Masking

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 113 NEWS #PharmaBuzz

media
2 DATA COMPILATION #PharmaFlow
113 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 Finished Drug Prices, 7 Annual Reports

globalSalesInformation
6 Finished Drug Prices
7 Annual Reports

MARKET PLACE

2 APIs, 2 FDF Dossiers

marketPlace
2 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

35 US Patents, 3 US Exclusivities

patents
35 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)

$ 13,685

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

55DRUGS 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

113

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

2,614

Finished Drug Prices

43 RELATED EXCIPIENT COMPANIES

64EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: 1038915-73-9, Mk-4827 tosylate, Mk-4827 (tosylate), Mk-4827-tosylate, Niraparib (tosylate), Mk 4827 tosylate

Molecular Formula

C₂₆H₂₈N₄O₄S

Molecular Weight

492.6 g/mol

InChI Key

LCPFHXWLJMNKNC-PFEQFJNWSA-N

FDA UNII

75KE12AY9U

1 2D Structure

Niraparib Tosylate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-methylbenzenesulfonic acid;2-[4-[(3S)-piperidin-3-yl]phenyl]indazole-7-carboxamide

2.1.2 InChI

InChI=1S/C19H20N4O.C7H8O3S/c20-19(24)17-5-1-3-15-12-23(22-18(15)17)16-8-6-13(7-9-16)14-4-2-10-21-11-14;1-6-2-4-7(5-3-6)11(8,9)10/h1,3,5-9,12,14,21H,2,4,10-11H2,(H2,20,24);2-5H,1H3,(H,8,9,10)/t14-;/m1./s1

2.1.3 InChI Key

LCPFHXWLJMNKNC-PFEQFJNWSA-N

2.1.4 Canonical SMILES

CC1=CC=C(C=C1)S(=O)(=O)O.C1CC(CNC1)C2=CC=C(C=C2)N3C=C4C=CC=C(C4=N3)C(=O)N

2.1.5 Isomeric SMILES

CC1=CC=C(C=C1)S(=O)(=O)O.C1C[C@H](CNC1)C2=CC=C(C=C2)N3C=C4C=CC=C(C4=N3)C(=O)N

2.2 Other Identifiers

2.2.1 UNII

75KE12AY9U

2.3 Synonyms

2.3.1 Depositor-Supplied Synonyms

1. 1038915-73-9

2. Mk-4827 Tosylate

3. Mk-4827 (tosylate)

4. Mk-4827-tosylate

5. Niraparib (tosylate)

6. Mk 4827 Tosylate

7. Niraparib (mk-4827) Tosylate

8. (s)-2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide 4-methylbenzenesulfonate

9. 75ke12ay9u

10. Mk-4827(niraparib) Tosylate

11. 2h-indazole-7-carboxamide, 2-(4-(3s)-3-piperidinylphenyl)-, 4-methylbenzenesulfonate (1:1)

12. Unii-75ke12ay9u

13. Niraparib Tosylate Monohyrate

14. Niraparib(mk-4827) Tosylate

15. Schembl20522624

16. Dtxsid801026487

17. Hy-10619b

18. Mfcd28167748

19. S7625

20. Ccg-269634

21. Niraparib Tosylate [orange Book]

22. Ac-30383

23. As-56981

24. A11848

25. A909268

26. Q27266392

27. (3s)-3-[4-[7-(aminocarbonyl)-2h-indazol-2-yl]phenyl]piperidine Tosylate

28. (s)-2-(4-(piperidin-3-yl)phenyl)-2h-indazole-7-carboxamide 4-?methylbenzenesulfona?te

29. 4-methylbenzenesulfonic Acid;2-[4-[(3s)-piperidin-3-yl]phenyl]indazole-7-carboxamide

30. 2-{4-[(3s)-piperidin-3-yl]phenyl}-2h-indazole-7-carboxamide; 4-methylbenzene-1-sulfonic Acid

2.4 Create Date

2014-10-10

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₂₈N₄O₄S
Molecular Weight	492.6 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	4
Exact Mass	492.18312656 g/mol
Monoisotopic Mass	492.18312656 g/mol
Topological Polar Surface Area	136 Å²
Heavy Atom Count	35
Formal Charge	0
Complexity	655
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
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 Information

1 of 1
Drug Name	ZEJULA
Active Ingredient	NIRAPARIB TOSYLATE
Company	TESARO INC (Application Number: N208447. Patents: 8071623, 8436185)

API SUPPLIERS

01

Seqens

France

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

CPHI Middle east

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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France

Virtual Booth

Digital Content

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

02

Dr. Reddy's Laboratories

India

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

CPHI Middle east

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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India

Virtual Booth

Digital Content

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

03

Shandong Loncom Pharmaceutical

China

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

CPHI Middle east

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Contact Supplier

China

Virtual Booth

Digital Content

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

Shandong Loncom Pharmaceutical company banner

04

Sichuan Elixir Pharmaceuticals

China

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

CPHI Middle east

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

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

05

Porton Pharma Solutions

China

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

CPHI Middle east

Not Confirmed

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

Contact Supplier

China

Virtual Booth

Digital Content

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

06

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

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07

Anhui HaiKang Pharmaceutical

China

India

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

CPHI Middle east

Not Confirmed

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EU WC

01

Dishman Carbogen Amcis

India

CPHI Middle east

Not Confirmed

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NDC API

01

DISHMAN CARBOGEN AMCIS LIMITED

India

CPHI Middle east

Not Confirmed

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Listed Suppliers

01

Seqens

France

CPHI Middle east

Not Confirmed

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

Contact Supplier

France

Virtual Booth

Digital Content

Niraparib Tosylate

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.

02

Dr. Reddy's Laboratories

India

CPHI Middle east

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

India

Virtual Booth

Digital Content

Niraparib Tosylate

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale

03

Shandong Loncom Pharmaceutical

China

CPHI Middle east

Not Confirmed

Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.

Contact Supplier

China

Virtual Booth

Digital Content

Niraparib Tosylate

About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...

Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development Zone, Shandong Province, Shandong Loncom has operational API pilot tests and production bases adhering to international standards. With 13 production lines dedicated to oral solid preparations, oral liquid preparations and API, it is actively expanding its preparation workshops for small-volume injections, soft capsules, eye drops, topical medicines and innovative drug R&D centres.

04

Sichuan Elixir Pharmaceuticals

China

CPHI Middle east

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

Niraparib Tosylate

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.

05

Porton Pharma Solutions

China

CPHI Middle east

Not Confirmed

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

Contact Supplier

China

Virtual Booth

Digital Content

Niraparib Tosylate

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.

06

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

Niraparib Tosylate

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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