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01 2Reddy Holding GmbH

02 3ALFRED E TIEFENBACHER GmbH & Co KG

03 1#NAME?

04 3Accord Healthcare Slu

05 3Adalvo Limited

06 5Amgen Europe Bv

07 2Amgen Switzerland Ag

08 2Anabiosis S.A.

09 1Avansor Pharma Oy

10 2Celgene Europe Ltd

11 2Clonmel Healthcare Limited

12 2Krka Dd, Novo Mesto

13 1Noucor Health Sa

14 2Sandoz A/S

15 1Sandoz Pharmaceuticals Sa

16 2Sandoz Pharmaceuticals d.d.

17 1Stada Arzneimittel Ag

18 2Stada Nordic Aps

19 4Stada Pharmaceuticals Ag

20 1Tarbis Farma Sl

21 2Teva Bv

22 2Torrent Pharma (Malta) Limited

23 2Zentiva Ks

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : Authorised

Registration Country : Malta

Apremilast

Brand Name : Apremilast Reddy

Dosage Form : Film Coated Tablet

Dosage Strength : 30MG

Packaging :

Approval Date : 2025-06-20

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

Dr Reddy Company 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 : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2020

Registration Country : Germany

Tiefenbacher Compnay Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : Authorised

Registration Country : Malta

Apremilast

Brand Name : Apremilast Reddy

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG; 20MG; 30MG

Packaging :

Approval Date : 2025-06-20

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

Dr Reddy Company Banner

04

  • 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

05

  • 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

06

CTAD25
Not Confirmed
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CTAD25
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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07

CTAD25
Not Confirmed
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CTAD25
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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08

CTAD25
Not Confirmed
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CTAD25
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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09

CTAD25
Not Confirmed
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CTAD25
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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10

Anabiosis S.A.

Country
CTAD25
Not Confirmed
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Anabiosis S.A.

Country
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CTAD25
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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