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Berlin Chemie
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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Berlin Chemie

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

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DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 7 Europe

7 FDF Dossiers
7 Europe

REF. STANDARDS & IMPURITIES

1 Others

1 Others

Xls

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FILTER :

filter Active Ingredients Reset all filters

7 All

01 1DAPOXETINE HYDROCHLORIDE

02 3Edoxan Tosylate Monohydrate

03 2Ibuprophene

04 1Nebivolol Hydrochloride

filter Applicant Reset all filters

7 All

01 1Berlin-Chemie AG / MENARINI

02 6Berlin-Chemie Ag

filter Dosage Form Reset all filters

7 All

01 1Antic-calc Tablet, Film Coated

02 3Film Coated Tablet

03 2Oral Suspension

04 1Tablet

filter Dosage Reset all filters

7 All

01 115mg

02 120MG

03 130 mg

04 130mg

05 140MG

06 15MG

07 160mg

filter Country Reset all filters

7 All

01 1Norway

02 3Spain

03 3Sweden

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Brand Name : Priligy

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Brand Name : Priligy

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Regulatory Info :

Registration Country : Norway

DAPOXETINE HYDROCHLORIDE

Berlin Chemie

Dosage Form : Antic-calc Tablet, Film ...

Brand Name : Priligy

Dosage Strength : 30 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

Brand Name : Roteas

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Brand Name : Roteas

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Regulatory Info : Approved

Registration Country : Sweden

Edoxan Tosylate Monohydrate

Berlin Chemie

Dosage Form : Film Coated Tablet

Brand Name : Roteas

Dosage Strength : 15mg

Packaging :

Approval Date : 20/04/2017

Application Number : 20160813000087

Regulatory Info : Approved

Registration Country : Sweden

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03

Brand Name : Roteas

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Brand Name : Roteas

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Regulatory Info : Approved

Registration Country : Sweden

Edoxan Tosylate Monohydrate

Berlin Chemie

Dosage Form : Film Coated Tablet

Brand Name : Roteas

Dosage Strength : 30mg

Packaging :

Approval Date : 20/04/2017

Application Number : 20160813000094

Regulatory Info : Approved

Registration Country : Sweden

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04

Brand Name : Roteas

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Brand Name : Roteas

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Regulatory Info : Approved

Registration Country : Sweden

Edoxan Tosylate Monohydrate

Berlin Chemie

Dosage Form : Film Coated Tablet

Brand Name : Roteas

Dosage Strength : 60mg

Packaging :

Approval Date : 20/04/2017

Application Number : 20160813000100

Regulatory Info : Approved

Registration Country : Sweden

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05

Brand Name : Eudorlin Children

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Brand Name : Eudorlin Children

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Regulatory Info : Cancelled

Registration Country : Spain

Ibuprophene

Berlin Chemie

Dosage Form : Oral Suspension

Brand Name : Eudorlin Children

Dosage Strength : 20MG

Packaging :

Approval Date : 2012-10-04

Application Number : 76590

Regulatory Info : Cancelled

Registration Country : Spain

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06

Brand Name : Eudorlin

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Brand Name : Eudorlin

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Regulatory Info : Cancelled

Registration Country : Spain

Ibuprophene

Berlin Chemie

Dosage Form : Oral Suspension

Brand Name : Eudorlin

Dosage Strength : 40MG

Packaging :

Approval Date : 2020-07-24

Application Number : 80140

Regulatory Info : Cancelled

Registration Country : Spain

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07

Brand Name : Lobivon

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Brand Name : Lobivon

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Regulatory Info : Authorized

Registration Country : Spain

Nebivolol Hydrochloride

Berlin Chemie

Dosage Form : Tablet

Brand Name : Lobivon

Dosage Strength : 5MG

Packaging :

Approval Date : 2018-10-19

Application Number : 4040

Regulatory Info : Authorized

Registration Country : Spain

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