Niraparib | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Niraparib
Europe

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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

Filters

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22 All

01 6GlaxoSmithKline (Ireland) Limited

02 4Glaxosmithkline (Ireland) Limited

03 2Glaxosmithkline (Ireland)Limited

04 2Glaxosmithkline Ag

05 2Janssen - Cilag International

06 2Janssen-Cilag Ag

07 2Janssen-Cilag International N.V.

08 2Janssen-Cilag International Nv

filter Active Ingredients Reset all filters

22 All

01 4Abiraterone Acetate; Niraparib Tosylate Monohydrate

02 2Niraparib

03 4Niraparib Tosylate Monohydrate

04 2Niraparib; Abiraterone

05 2Niraparib; Abiraterone Acetate

06 6Niraparibtosilatmonohydrat

07 2Niraparibum

filter Dosage Form Reset all filters

22 All

01 4Capsule

02 13Film Coated Tablet

03 3Film-Coated Tablet

04 1Hard Capsule

05 1Hard Capsules

filter Country Reset all filters

22 All

01 4Denmark

02 4Estonia

03 6Norway

04 4Spain

05 4Switzerland

filter Brand Name Reset all filters

22 All

01 6Akeega

02 2Akeega mg

03 13Zejula

04 1Zejula capsules

Niraparib Tosylate

List of Suppliers

Product Main Page

01

GlaxoSmithKline (Ireland) Limited

ASPEN

Not Confirmed

GlaxoSmithKline (Ireland) Limited

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

02

GlaxoSmithKline (Ireland) Limited

ASPEN

Not Confirmed

GlaxoSmithKline (Ireland) Limited

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

03

GlaxoSmithKline (Ireland) Limited

ASPEN

Not Confirmed

GlaxoSmithKline (Ireland) Limited

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

04

GlaxoSmithKline (Ireland) Limited

ASPEN

Not Confirmed

GlaxoSmithKline (Ireland) Limited

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

05

GlaxoSmithKline (Ireland) Limited

ASPEN

Not Confirmed

GlaxoSmithKline (Ireland) Limited

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

06

GlaxoSmithKline (Ireland) Limited

ASPEN

Not Confirmed

GlaxoSmithKline (Ireland) Limited

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

07

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

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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

08

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

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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

09

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Niraparib Tosylate Monohydrate

Brand Name : Zejula

Dosage Form : Film Coated Tablet

Dosage Strength : 100MG

Packaging :

Approval Date : 12-04-2024

Application Number : 1171235006

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Glaxosmithkline (Ireland) Limited

ASPEN

Not Confirmed

Glaxosmithkline (Ireland) Limited

ASPEN

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 : Authorized

Registration Country : Spain

Niraparib Tosylate Monohydrate

Brand Name : Zejula

Dosage Form : Hard Capsule

Dosage Strength : 100MG

Packaging :

Approval Date : 08-03-2018

Application Number : 1171235001

Regulatory Info : Authorized

Registration Country : Spain

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Corporate PDF

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.