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01 3ALFRED E TIEFENBACHER GmbH & Co KG

02 3Accord Healthcare Slu

03 1Adalvo Limited

04 5Amgen Europe Bv

05 2Amgen Switzerland Ag

06 2Anabiosis S.A.

07 1Avansor Pharma Oy

08 2Celgene Europe Ltd

09 2Krka Dd, Novo Mesto

10 1Noucor Health Sa

11 2Sandoz A/S

12 1Sandoz Pharmaceuticals Sa

13 1Stada Arzneimittel Ag

14 2Stada Nordic Aps

15 4Stada Pharmaceuticals Ag

16 1Tarbis Farma Sl

17 2Teva Bv

18 2Zentiva Ks

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Apremilast

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Apremilast

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Apremilast

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

04

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Apremilast

Brand Name : Apremilast Accord

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg, 20mg, 30mg

Packaging :

Approval Date : 19/04/2024

Application Number : 20230307000029

Regulatory Info : Approved

Registration Country : Sweden

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05

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Apremilast

Brand Name : Apremilast Accord

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 19/04/2024

Application Number : 20230307000036

Regulatory Info : Approved

Registration Country : Sweden

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06

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Apremilast

Brand Name : Otezla

Dosage Form :

Dosage Strength :

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

BioJapan
Not Confirmed
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BioJapan
Not Confirmed

Apremilast

Brand Name : Otezla

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 30 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

Anabiosis S.A.

Country
BioJapan
Not Confirmed
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Anabiosis S.A.

Country
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BioJapan
Not Confirmed

Apremilast

Brand Name : Apremilast Anabiosis

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg,20mg,30mg

Packaging :

Approval Date : 25/06/2024

Application Number : 20230201000132

Regulatory Info : Approved

Registration Country : Sweden

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09

Anabiosis S.A.

Country
BioJapan
Not Confirmed
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Anabiosis S.A.

Country
arrow
BioJapan
Not Confirmed

Apremilast

Brand Name : Apremilast Anabiosis

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 25/06/2024

Application Number : 20230201000149

Regulatory Info : Approved

Registration Country : Sweden

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10

Avansor Pharma Oy

Country
BioJapan
Not Confirmed
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Avansor Pharma Oy

Country
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BioJapan
Not Confirmed

Apremilast

Brand Name : Apremilast Avansor

Dosage Form : Film Coated Tablet

Dosage Strength : 30mg

Packaging :

Approval Date : 14/05/2024

Application Number : 20230118000027

Regulatory Info : Approved

Registration Country : Sweden

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