Eurocept Pharmaceuticals | EU CTD Dossiers | In | Out | Licensing | PharmaCompass.com

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Eurocept Pharmaceuticals
FDF Dossiers

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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

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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Eurocept Pharmaceuticals

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FINISHED DOSAGE FORMULATIONS

21 FDF Dossiers, 21 Europe

21 FDF Dossiers
21 Europe

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filter Active Ingredients Reset all filters

21 All

01 1Aminosalicylic Acid

02 3Amsacrine

03 1Carglumic Acid

04 1Carglumic acid

05 1Chloramphenicol Sodium Succinate

06 2Esketamine Hydrochloride

07 1Lidocaine; Tetracaine

08 2Midazolam

09 6Morfinhydrokloridtrihydrat

10 1Oxytetracycline Hydrochloride; Polymyxin B Sulfate

11 2Sodium Phenylbutyrate

filter Applicant Reset all filters

21 All

01 1EUROCEPT INTERNATIONAL BV

02 17Eurocept International Bv

03 3Nordmedica A/S

filter Dosage Form Reset all filters

21 All

01 2Concentrate And Solvent For Concentrate For Solution For Infusion

02 1Dispersible Tablet

03 1Dispersible Tablet Oral Use Blister

04 2Granules

05 5Infusion Solution

06 5Injectable Solution

07 1Oral Solution

08 1Patch

09 1Powder For Concentrate For Solution For Infusion

10 1Powder For Solution For Injection

11 1Salve

filter Dosage Reset all filters

21 All

01 210mg/ml

02 11g

03 31mg/ml

04 1200 mg

05 1200mg

06 220mg/ml

07 125mg/ml

08 130mg/g;1mg/g

09 1350mg/ml

10 1483mg/g

11 14g

12 25mg/ml

13 170mg/70mg

14 175mg

15 275mg/1.5ml

filter Country Reset all filters

21 All

01 1Italy

02 20Sweden

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01

Brand Name : Granupas

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Brand Name : Granupas

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Regulatory Info : Approved

Registration Country : Sweden

Aminosalicylic Acid

Eurocept Pharmaceuticals

Dosage Form : Granules

Brand Name : Granupas

Dosage Strength : 4g

Packaging :

Approval Date : 07/04/2014

Application Number : 20120401000011

Regulatory Info : Approved

Registration Country : Sweden

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02

Brand Name : Amekrin

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Brand Name : Amekrin

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Regulatory Info : Approved

Registration Country : Sweden

Eurocept Pharmaceuticals

Dosage Form : Concentrate And Solvent ...

Brand Name : Amekrin

Dosage Strength : 75mg/1.5ml

Packaging :

Approval Date : 22/06/2016

Application Number : 20131115000068

Regulatory Info : Approved

Registration Country : Sweden

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03

Brand Name : Amsalyo

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Brand Name : Amsalyo

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Regulatory Info : Approved

Registration Country : Sweden

Eurocept Pharmaceuticals

Dosage Form : Powder For Concentrate F...

Brand Name : Amsalyo

Dosage Strength : 75mg

Packaging :

Approval Date : 14/06/2018

Application Number : 20170418000030

Regulatory Info : Approved

Registration Country : Sweden

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04

Brand Name : Amekrin

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Brand Name : Amekrin

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Regulatory Info : Deregistered

Registration Country : Sweden

Dosage Form : Concentrate And Solvent ...

Brand Name : Amekrin

Dosage Strength : 75mg/1.5ml

Packaging :

Approval Date : 28/04/1983

Application Number : 19830428000027

Regulatory Info : Deregistered

Registration Country : Sweden

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Brand Name : UCEDANE

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Brand Name : UCEDANE

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Regulatory Info :

Registration Country : Italy

Carglumic acid

Eurocept Pharmaceuticals

Dosage Form : Dispersible Tablet Oral ...

Brand Name : UCEDANE

Dosage Strength : 200 mg

Packaging : 60 UNITS 200 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

Brand Name : Ucedane

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Brand Name : Ucedane

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Regulatory Info : Approved

Registration Country : Sweden

Carglumic Acid

Eurocept Pharmaceuticals

Dosage Form : Dispersible Tablet

Brand Name : Ucedane

Dosage Strength : 200mg

Packaging :

Approval Date : 23/06/2017

Application Number : 20160427000046

Regulatory Info : Approved

Registration Country : Sweden

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07

Brand Name : Chloramphenicol Succ...

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Brand Name : Chloramphenicol Succ...

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Regulatory Info : Deregistered

Registration Country : Sweden

Chloramphenicol Sodium Succinate

Dosage Form : Powder For Solution For ...

Brand Name : Chloramphenicol Succinate

Dosage Strength : 1g

Packaging :

Approval Date : 27/11/1961

Application Number : 19611127000019

Regulatory Info : Deregistered

Registration Country : Sweden

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08

Brand Name : Sinmelan

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Brand Name : Sinmelan

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Regulatory Info : Approved

Registration Country : Sweden

Esketamine Hydrochloride

Eurocept Pharmaceuticals

Dosage Form : Injectable Solution

Brand Name : Sinmelan

Dosage Strength : 25mg/ml

Packaging :

Approval Date : 31/07/2018

Application Number : 20170502000045

Regulatory Info : Approved

Registration Country : Sweden

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09

Brand Name : Sinmelan

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Brand Name : Sinmelan

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Regulatory Info : Approved

Registration Country : Sweden

Esketamine Hydrochloride

Eurocept Pharmaceuticals

Dosage Form : Injectable Solution

Brand Name : Sinmelan

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 31/07/2018

Application Number : 20170502000038

Regulatory Info : Approved

Registration Country : Sweden

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10

Brand Name : Rapydan

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Brand Name : Rapydan

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Regulatory Info : Approved

Registration Country : Sweden

Lidocaine; Tetracaine

Eurocept Pharmaceuticals

Dosage Form : Patch

Brand Name : Rapydan

Dosage Strength : 70mg/70mg

Packaging :

Approval Date : 26/01/2007

Application Number : 20050512000016

Regulatory Info : Approved

Registration Country : Sweden

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