Amifampridine | All | Licensing, EU CTD Dossiers, Formulation Suppliers | PharmaCompass.com

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Amifampridine
FDF Dossiers

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Amifampridine

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

4 API Suppliers, 2 USDMF, 1 NDC API, 1 Listed Suppliers, $ API Reference Price

4 API Suppliers
2 USDMF
1 NDC API
1 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 1 FDA Orange Book, 4 Europe, 1 Canada, 1 Australia

7 FDF Dossiers
1 FDA Orange Book
4 Europe
1 Canada
1 Australia

DIGITAL CONTENT

39 News #PharmaBuzz

39 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 Regulatory FDF Prices, 5 Annual Reports

1 Regulatory FDF Prices
5 Annual Reports

MARKET PLACE

2 APIs

2 APIs

$ API Ref.Price (USD/KG) : 37,072 Xls

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7 All

01 1BioMarin Pharmaceutical

02 1Drac Ag

03 1Jacobus Pharmaceutical Company, Inc

04 1MEDUNIK CANADA

05 1Orspec Pharma

06 2Serb

filter Dosage Reset all filters

7 All

01 1Antic-calc Tablet

02 1TABLET

03 1TABLET;ORAL

04 3Tablet

05 1Blank

filter Regulatory Info Reset all filters

7 All

01 1Allowed

02 2Approved

03 4Blank

filter Brand Name Reset all filters

7 All

01 1Amifampridine Serb

02 3Firdapse

03 2RUZURGI

04 1Ruzurgi

filter Country Reset all filters

7 All

01 1Australia

02 1Canada

03 1Norway

04 2Sweden

05 1Switzerland

06 1USA

List of Suppliers

Product Main Page

01

BioMarin Pharmaceutical

PREP

Not Confirmed

BioMarin Pharmaceutical

PREP

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Norway

Amifampridine

Brand Name : Firdapse

Dosage Form : Antic-calc Tablet

Dosage Strength : 10 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Jacobus Pharmaceutical Company, Inc

U.S.A

PREP

Not Confirmed

Jacobus Pharmaceutical Company, Inc

U.S.A

PREP

Not Confirmed

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U.S.A

Digital Content

Regulatory Info :

Registration Country : USA

AMIFAMPRIDINE

Brand Name : RUZURGI

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 209321

Regulatory Info :

Registration Country : USA

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

03

MEDUNIK CANADA

PREP

Not Confirmed

MEDUNIK CANADA

PREP

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Digital Content

Regulatory Info :

Registration Country : Canada

AMIFAMPRIDINE

Brand Name : RUZURGI

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2503034

Regulatory Info :

Registration Country : Canada

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Orspec Pharma

PREP

Not Confirmed

Orspec Pharma

PREP

Not Confirmed

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Digital Content

Regulatory Info :

Registration Country : Australia

Amifampridine

Brand Name : Ruzurgi

Dosage Form :

Dosage Strength :

Packaging : 100

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Serb

PREP

Not Confirmed

Serb

PREP

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Amifampridine Phosphate

Brand Name : Amifampridine Serb

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 19/05/2022

Application Number : 20210429000015

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Serb

PREP

Not Confirmed

Serb

PREP

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Amifampridine Phosphate

Brand Name : Firdapse

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 23/12/2009

Application Number : 20080611000020

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Drac Ag

Country

PREP

Not Confirmed

Drac Ag

Country

PREP

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Allowed

Registration Country : Switzerland

Amifampridine

Brand Name : Firdapse

Dosage Form : Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 22/08/2012

Application Number : 61853

Regulatory Info : Allowed

Registration Country : Switzerland

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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