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Niraparib Tosylate
FDF Dossiers

Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

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xyz-pharma-m-2025-06-09

Niraparib Tosylate

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 1 USDMF, 1 NDC API, 12 Listed Suppliers, $ API Reference Price

13 API Suppliers
1 USDMF
1 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers, 4 FDA Orange Book, 6 Europe, 3 Canada, 8 Australia

21 FDF Dossiers
4 FDA Orange Book
6 Europe
3 Canada
8 Australia

RELATED EXCIPIENT COMPANIES

2 DKSH, 2 Faran Shimi Pharmaceutical, 2 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, 1 Sigachi Industries, 1 Silverline Chemicals, 1 Vasa Pharmachem

2 DKSH
2 Faran Shimi Pharmaceutical
2 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
1 Sigachi Industries
1 Silverline Chemicals
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

23 Fillers, Diluents & Binders, 8 Lubricants & Glidants, 5 Coating Systems & Additives, 4 Granulation, 3 Co-Processed Excipients, 3 Direct Compression, 2 Film Formers & Plasticizers, 2 Coloring Agents, 1 Parenteral, 1 Taste Masking, 1 Emulsifying Agents, 1 Thickeners and Stabilizers

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 114 News #PharmaBuzz

1 Data Compilation #PharmaFlow
114 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 Regulatory FDF Prices, 9 Annual Reports

6 Regulatory FDF Prices
9 Annual Reports

MARKET PLACE

2 APIs, 2 FDF Dossiers

2 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

35 US Patents, 2 US Exclusivities

35 US Patents
2 US Exclusivities

$ API Ref.Price (USD/KG) : 13,756 Xls

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21 All

01 2Centocor

02 19GSK

filter Dosage Reset all filters

21 All

01 1CAPSULE;ORAL

02 2Filmtabl

03 2Kaps

04 3TABLET

05 3TABLET;ORAL

06 2Tablet, film-coated

07 8Blank

filter Regulatory Info Reset all filters

21 All

01 1DISCN

02 3Prescription

03 3RX

04 14Blank

filter Brand Name Reset all filters

21 All

01 2AKEEGA

02 5ZEJULA

03 14Zejula

filter Country Reset all filters

21 All

01 8Australia

02 3Canada

03 2Norway

04 4Switzerland

05 4USA

List of Suppliers

Product Main Page

01

Centocor

Simposio AFI

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Centocor

Simposio AFI

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

Niraparib Tosylate

Brand Name : AKEEGA

Dosage Form : TABLET

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 2538555

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Centocor

Simposio AFI

Not Confirmed

Centocor

Simposio AFI

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

Niraparib Tosylate

Brand Name : AKEEGA

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2538563

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

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Digital Content

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03

GSK

Simposio AFI

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GSK

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Digital Content

Regulatory Info : DISCN

Registration Country : USA

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2017-03-27

Application Number : 208447

Regulatory Info : DISCN

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

GSK

Simposio AFI

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GSK

Simposio AFI

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Regulatory Info : RX

Registration Country : USA

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2023-04-26

Application Number : 214876

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Regulatory Info : RX

Registration Country : USA

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 200MG BASE

Packaging :

Approval Date : 2023-04-26

Application Number : 214876

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Digital Content

Regulatory Info : RX

Registration Country : USA

NIRAPARIB TOSYLATE

Brand Name : ZEJULA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Packaging :

Approval Date : 2023-04-26

Application Number : 214876

Regulatory Info : RX

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Packaging : Blisterpakning 56item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

Not Confirmed

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Regulatory Info :

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Tablet, film-coated

Dosage Strength : 100 mg

Packaging : Blisterpakning 84item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Niraparibum

Brand Name : Zejula

Dosage Form : Kaps

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Regulatory Info :

Registration Country : Switzerland

Niraparibum

Brand Name : Zejula

Dosage Form : Kaps

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

11

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Digital Content

Regulatory Info :

Registration Country : Switzerland

Niraparibum

Brand Name : Zejula

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

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12

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Regulatory Info :

Registration Country : Switzerland

Niraparibum

Brand Name : Zejula

Dosage Form : Filmtabl

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

13

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

Not Confirmed

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Digital Content

Regulatory Info : Prescription

Registration Country : Canada

Niraparib Tosylate

Brand Name : ZEJULA

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 2530031

Regulatory Info : Prescription

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

14

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Product Web Link

Digital Content

Corporate PDF

15

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Product Web Link

Digital Content

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16

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Digital Content

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17

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Product Web Link

Digital Content

Corporate PDF

18

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

19

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 56

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

20

GSK

Simposio AFI

Not Confirmed

GSK

Simposio AFI

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info :

Registration Country : Australia

Brand Name : Zejula

Dosage Form :

Dosage Strength :

Packaging : 84

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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