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Niraparib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 3 USDMF, 1 KDMF, 2 NDC API, 10 Listed Suppliers, $ API Reference Price

13 API Suppliers
3 USDMF
1 KDMF
2 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

156 Drugs in Development

156 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

39 FDF Dossiers, 4 FDA Orange Book, 22 Europe, 3 Canada, 8 Australia, 2 South Africa

39 FDF Dossiers
4 FDA Orange Book
22 Europe
3 Canada
8 Australia
2 South Africa

RELATED EXCIPIENT COMPANIES

2 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 DFE Pharma, 1 Gangwal Chemicals, 9 Kerry, 7 Microlex e.U, 1 Nitika Pharmaceutical Specialities, 2 Pluviaendo, 1 Prachin Chemical, 2 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 1 Silverline Chemicals, 1 Vasa Pharmachem

2 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 DFE Pharma
1 Gangwal Chemicals
9 Kerry
7 Microlex e.U
1 Nitika Pharmaceutical Specialities
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

14 Fillers, Diluents & Binders, 8 Lubricants & Glidants, 7 Granulation, 5 Direct Compression, 3 Coating Systems & Additives, 2 Co-Processed Excipients, 2 Film Formers & Plasticizers, 1 Parenteral, 1 Taste Masking, 1 Emulsifying Agents, 1 Thickeners and Stabilizers

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

DIGITAL CONTENT

119 News #PharmaBuzz

119 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 9 Annual Reports

2 US Medicaid Prescriptions
9 Annual Reports

MARKET PLACE

2 APIs, 2 FDF Dossiers

2 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

35 US Patents, 2 US Exclusivities, 14 Health Canada Patents

35 US Patents
2 US Exclusivities
14 Health Canada Patents

$ API Ref.Price (USD/KG) : 13,930 Xls

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39 All

01 2Centocor

02 27GSK

03 8Janssen-Cilag

04 2Johnson & Johnson Innovative Medicine

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39 All

01 1CAPSULE;ORAL

02 4Capsule

03 2FCT

04 13Film Coated Tablet

05 3Film-Coated Tablet

06 1Hard Capsule

07 1Hard Capsules

08 3TABLET

09 3TABLET;ORAL

10 8Blank

filter Regulatory Info Reset all filters

39 All

01 4Allowed

02 4Authorized

03 1DISCN

04 4Marketed

05 2Not Marketed

06 2Originator

07 11Prescription

08 3RX

09 8Blank

filter Brand Name Reset all filters

39 All

01 2AKEEGA

02 1AKEEGA 100 mg /500 mg

03 1AKEEGA 50 mg /500 mg

04 6Akeega

05 2Akeega mg

06 5ZEJULA

07 21Zejula

08 1Zejula capsules

filter Country Reset all filters

39 All

01 8Australia

02 3Canada

03 4Denmark

04 4Estonia

05 6Norway

06 2South Africa

07 4Spain

08 4Switzerland

09 4USA

Niraparib Tosylate

List of Suppliers

Product Main Page

01

GSK

ASPEN

Not Confirmed

GSK

ASPEN

Not Confirmed

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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

02

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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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

03

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

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

04

GSK

ASPEN

Not Confirmed

GSK

ASPEN

Not Confirmed

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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

05

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Niraparibum

Brand Name : Zejula capsules

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date : 03/10/2018

Application Number : 66763

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Niraparibum

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 20/01/2023

Application Number : 68652

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

GSK

ASPEN

Not Confirmed

GSK

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Not Marketed

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

Regulatory Info : Not Marketed

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Not Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

GSK

ASPEN

Not Confirmed

GSK

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

GSK

ASPEN

Not Confirmed

GSK

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

11

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

12

GSK

ASPEN

Not Confirmed

GSK

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Niraparibtosilatmonohydrat

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

13

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Zejula

Dosage Form : Capsule

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

14

GSK

ASPEN

Not Confirmed

GSK

ASPEN

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Digital Content

Regulatory Info : Prescription

Registration Country : Estonia

Brand Name : Zejula

Dosage Form : Film-Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

15

Janssen-Cilag

ASPEN

Not Confirmed

Janssen-Cilag

ASPEN

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Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Niraparib; Abiraterone Acetate

Brand Name : Akeega mg

Dosage Form : Film Coated Tablet

Dosage Strength : 50mg;500mg

Packaging :

Approval Date : 18/04/2024

Application Number : 68977

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

16

Janssen-Cilag

ASPEN

Not Confirmed

Janssen-Cilag

ASPEN

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Regulatory Info : Allowed

Registration Country : Switzerland

Niraparib; Abiraterone Acetate

Brand Name : Akeega mg

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg;500mg

Packaging :

Approval Date : 18/04/2024

Application Number : 68977

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

17

Janssen-Cilag

ASPEN

Not Confirmed

Janssen-Cilag

ASPEN

Not Confirmed

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Regulatory Info : Prescription

Registration Country : Estonia

Niraparib; Abiraterone

Brand Name : Akeega

Dosage Form : Film-Coated Tablet

Dosage Strength : 50mg; 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

18

Janssen-Cilag

ASPEN

Not Confirmed

Janssen-Cilag

ASPEN

Not Confirmed

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Regulatory Info : Prescription

Registration Country : Estonia

Niraparib; Abiraterone

Brand Name : Akeega

Dosage Form : Film-Coated Tablet

Dosage Strength : 100mg; 500mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

Portfolio PDF

Product Web Link

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19

Janssen-Cilag

ASPEN

Not Confirmed

Janssen-Cilag

ASPEN

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Regulatory Info : Authorized

Registration Country : Spain

Abiraterone Acetate; Niraparib Tosylate Monohydrate

Brand Name : Akeega

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG; 500 MG

Packaging :

Approval Date : 27-04-2023

Application Number : 1231722002

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

20

Janssen-Cilag

ASPEN

Not Confirmed

Janssen-Cilag

ASPEN

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Regulatory Info : Authorized

Registration Country : Spain

Abiraterone Acetate; Niraparib Tosylate Monohydrate

Brand Name : Akeega

Dosage Form : Film Coated Tablet

Dosage Strength : 50MG; 500 MG

Packaging :

Approval Date : 27-04-2023

Application Number : 1231722001

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

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Corporate PDF

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