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01 1ALFRED E TIEFENBACHER GmbH & Co KG

02 1ACTELION REGISTRATION LTD

03 1Abacus Medicine A/S

04 2Accord Healthcare Slu

05 1Actelion Pharmaceuticals Ltd

06 1Clonmel Healthcare Limited

07 1Deva Holding A.?.

08 1Devatis Gmbh

09 1Glenmark Arzneimittel Gmbh

10 4Janssen - Cilag International

11 1Janssen-Cilag Ag

12 3Janssen-Cilag International N.V.

13 1Janssen-Cilag International NV

14 6Janssen-Cilag International Nv

15 1Newbury Pharmaceuticals Ab

16 1Norameda Uab

17 1PharmaPath S.A.

18 1Pharmascience International Ltd

19 1Reddy Pharma Iberia Sa

20 1Reig Jofre Laboratory, Sa

21 1Stada Laboratory Sl

22 2Teva Gmbh

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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-Q4 2023

Registration Country : Germany

Macitentan

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q4 2023

Registration Country : Germany

Tiefenbacher Compnay Banner

02

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
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Macitentan

Brand Name : Macitentan Devatis

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 03/07/2025

Application Number : 20240314000073

Regulatory Info : Approved

Registration Country : Sweden

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03

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
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Macitentan

Brand Name : Macitentan Glenmark

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 24/03/2025

Application Number : 20231221000157

Regulatory Info : Approved

Registration Country : Sweden

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04

IMCAS World Congress
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IMCAS World Congress
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Macitentan

Brand Name : Opsumit

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 20/12/2013

Application Number : 20121211000079

Regulatory Info : Approved

Registration Country : Sweden

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05

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
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Macitentan

Brand Name : Opsumit

Dosage Form : Dispersible Tablet

Dosage Strength : 2.5mg

Packaging :

Approval Date : 04/10/2024

Application Number : 20231009000171

Regulatory Info : Approved

Registration Country : Sweden

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06

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
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Macitentan; Tadalafil

Brand Name : Yuvanci

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg;20mg

Packaging :

Approval Date : 27/09/2024

Application Number : 20230623000024

Regulatory Info : Approved

Registration Country : Sweden

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07

IMCAS World Congress
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IMCAS World Congress
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Macitentan

Brand Name : Opsumit

Dosage Form : Macitentan 10Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr riv 10 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
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Macitantanum

Brand Name : Opsumit

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 06/02/2014

Application Number : 61863

Regulatory Info : Allowed

Registration Country : Switzerland

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09

IMCAS World Congress
Not Confirmed
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IMCAS World Congress
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Macitentan

Brand Name : Macitentan Teva

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 09/05/2025

Application Number : 20231228000105

Regulatory Info : Approved

Registration Country : Sweden

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10

Newbury Pharmaceuticals Ab

Country
IMCAS World Congress
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Newbury Pharmaceuticals Ab

Country
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IMCAS World Congress
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Macitentan

Brand Name : Macitentan Newbury

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 27/03/2025

Application Number : 20231221000010

Regulatory Info : Approved

Registration Country : Sweden

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