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Horizon Therapeutics
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

Horizon Therapeutics

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Corporate Presentation

Corporate Presentation

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 452 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
452 News #PharmaBuzz

DEVELOPMENTS

58 Drugs in Development

58 Drugs in Development

FINISHED DOSAGE FORMULATIONS

22 FDF Dossiers, 17 FDA Orange Book, 5 Canada

22 FDF Dossiers
17 FDA Orange Book
5 Canada

INSPECTIONS & REGISTRATIONS

3 FDA

3 FDA

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filter Active Ingredients Reset all filters

22 All

01 2CYSTEAMINE (CYSTEAMINE BITARTRATE)

02 4CYSTEAMINE BITARTRATE

03 1DICLOFENAC SODIUM

04 2ESOMEPRAZOLE MAGNESIUM; NAPROXEN

05 1FAMOTIDINE; IBUPROFEN

06 2GLYCEROL PHENYLBUTYRATE

07 1INEBILIZUMAB

08 1INTERFERON GAMMA-1B

09 1LEVOFLOXACIN (LEVOFLOXACIN HEMIHYDRATE)

10 1PEGLOTICASE

11 3PREDNISONE

12 2SODIUM PHENYLBUTYRATE

13 1TEPROTUMUMAB-TRBW

filter Applicant Reset all filters

22 All

01 11HORIZON

02 1HORIZON PHARMA

03 3HORIZON THERAP US

04 1HORIZON THERAPEUTICS IRELAND

05 6HORIZON THERAPEUTICS IRELAND DAC

filter Dosage Form Reset all filters

22 All

01 2CAPSULE (DELAYED RELEASE)

02 2CAPSULE, DELAYED RELEASE;ORAL

03 2GRANULE, DELAYED RELEASE;ORAL

04 1INJECTABLE; INJECTION

05 1INJECTABLE;INJECTION

06 1LIQUID

07 1LIQUID;ORAL

08 1POWDER;ORAL

09 2SOLUTION

10 1SOLUTION;TOPICAL

11 5TABLET, DELAYED RELEASE;ORAL

12 2TABLET;ORAL

13 1VIAL; SINGLE-USE

filter Dosage Reset all filters

22 All

01 11.1G/ML

02 11.1GM/ML

03 1100UG/0.5ML

04 110MG/ML

05 11MG

06 12% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

07 1240MG/2.4ML

08 125MG

09 126.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

10 12MG

11 13GM/TEASPOONFUL

12 2500MG

13 15MG

14 175MG

15 18MG

16 1EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

17 1EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

18 1EQ 25MG BASE

19 1EQ 300MG BASE/PACKET

20 1EQ 75MG BASE

21 1EQ 75MG BASE/PACKET

filter Country Reset all filters

22 All

01 5Canada

02 17USA

List of Suppliers

Supplier Virtual Booth

price-trend

01

Brand Name : PROCYSBI

IOPC

Not Confirmed

Brand Name : PROCYSBI

IOPC

Not Confirmed

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Regulatory Info : Prescription

Registration Country : Canada

CYSTEAMINE (CYSTEAMINE BITARTRATE)

Horizon Therapeutics

Dosage Form : CAPSULE (DELAYED RELEASE...

Brand Name : PROCYSBI

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number : 2464713

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

Stock Recap
#PipelineProspector

02

Brand Name : PROCYSBI

IOPC

Not Confirmed

Brand Name : PROCYSBI

IOPC

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.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : Prescription

Registration Country : Canada

CYSTEAMINE (CYSTEAMINE BITARTRATE)

Horizon Therapeutics

Dosage Form : CAPSULE (DELAYED RELEASE...

Brand Name : PROCYSBI

Dosage Strength : 25MG

Packaging : 50

Approval Date :

Application Number : 2464705

Regulatory Info : Prescription

Registration Country : Canada

Product
Web Link

Stock Recap
#PipelineProspector

03

Brand Name : PROCYSBI

IOPC

Not Confirmed

Brand Name : PROCYSBI

IOPC

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 : RX

Registration Country : USA

CYSTEAMINE BITARTRATE

Horizon Therapeutics

Dosage Form : CAPSULE, DELAYED RELEASE...

Brand Name : PROCYSBI

Dosage Strength : EQ 25MG BASE

Packaging :

Approval Date : 2013-04-30

Application Number : 203389

Regulatory Info : RX

Registration Country : USA

Product
Web Link

Stock Recap
#PipelineProspector

04

Brand Name : PROCYSBI

IOPC

Not Confirmed

Brand Name : PROCYSBI

IOPC

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 : RX

Registration Country : USA

CYSTEAMINE BITARTRATE

Horizon Therapeutics

Dosage Form : CAPSULE, DELAYED RELEASE...

Brand Name : PROCYSBI

Dosage Strength : EQ 75MG BASE

Packaging :

Approval Date : 2013-04-30

Application Number : 203389

Regulatory Info : RX

Registration Country : USA

Product
Web Link

Stock Recap
#PipelineProspector

05

Brand Name : PROCYSBI

IOPC

Not Confirmed

Brand Name : PROCYSBI

IOPC

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.

Post an Enquiry

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Digital Content

Regulatory Info : RX

Registration Country : USA

CYSTEAMINE BITARTRATE

Horizon Therapeutics

Dosage Form : GRANULE, DELAYED RELEASE...

Brand Name : PROCYSBI

Dosage Strength : EQ 75MG BASE/PACKET

Packaging :

Approval Date : 2020-02-14

Application Number : 213491

Regulatory Info : RX

Registration Country : USA

Product
Web Link

Stock Recap
#PipelineProspector

06

Brand Name : PROCYSBI

IOPC

Not Confirmed

Brand Name : PROCYSBI

IOPC

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 : RX

Registration Country : USA

CYSTEAMINE BITARTRATE

Horizon Therapeutics

Dosage Form : GRANULE, DELAYED RELEASE...

Brand Name : PROCYSBI

Dosage Strength : EQ 300MG BASE/PACKET

Packaging :

Approval Date : 2020-02-14

Application Number : 213491

Regulatory Info : RX

Registration Country : USA

Product
Web Link

Stock Recap
#PipelineProspector

07

Brand Name : PENNSAID

IOPC

Not Confirmed

Brand Name : PENNSAID

IOPC

Not Confirmed

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Digital Content

Regulatory Info : DISCN

Registration Country : USA

DICLOFENAC SODIUM

Horizon Therapeutics

Dosage Form : SOLUTION;TOPICAL

Brand Name : PENNSAID

Dosage Strength : 2% **Federal Register ...

Packaging :

Approval Date : 2014-01-16

Application Number : 204623

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

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08

Brand Name : VIMOVO

IOPC

Not Confirmed

Brand Name : VIMOVO

IOPC

Not Confirmed

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Digital Content

Regulatory Info : DISCN

Registration Country : USA

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Horizon Therapeutics

Dosage Form : TABLET, DELAYED RELEASE;...

Brand Name : VIMOVO

Dosage Strength : EQ 20MG BASE;500MG **F...

Packaging :

Approval Date : 2010-04-30

Application Number : 22511

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

Stock Recap
#PipelineProspector

09

Brand Name : VIMOVO

IOPC

Not Confirmed

Brand Name : VIMOVO

IOPC

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.

Post an Enquiry

Post an Enquiry

Digital Content

Regulatory Info : DISCN

Registration Country : USA

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Horizon Therapeutics

Dosage Form : TABLET, DELAYED RELEASE;...

Brand Name : VIMOVO

Dosage Strength : EQ 20MG BASE;375MG **F...

Packaging :

Approval Date : 2010-04-30

Application Number : 22511

Regulatory Info : DISCN

Registration Country : USA

Product
Web Link

Stock Recap
#PipelineProspector

10

Brand Name : DUEXIS

IOPC

Not Confirmed

Brand Name : DUEXIS

IOPC

Not Confirmed

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Digital Content

Regulatory Info : DISCN

Registration Country : USA

FAMOTIDINE; IBUPROFEN

Horizon Therapeutics

Dosage Form : TABLET;ORAL

Brand Name : DUEXIS

Dosage Strength : 26.6MG;800MG **Federal...

Packaging :

Approval Date : 2011-04-23

Application Number : 22519

Regulatory Info : DISCN

Registration Country : USA

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