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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 2Devatis Gmbh

09 2Glenmark Arzneimittel Gmbh

10 4Janssen - Cilag International

11 1Janssen-Cilag Ag

12 3Janssen-Cilag International N.V.

13 1Janssen-Cilag International NV

14 10Janssen-Cilag International Nv

15 2Newbury 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 3Teva 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

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Macitentan

Brand Name : Opsumit

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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03

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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Macitentan

Brand Name : Macitentan Accord

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 17-11-2025

Application Number : 1251970004

Regulatory Info : Authorized

Registration Country : Spain

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04

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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Macitentan

Brand Name : Macitentan Accordpharma

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 18-11-2025

Application Number : 1251971004

Regulatory Info : Authorized

Registration Country : Spain

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05

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Macitentan

Brand Name : Macitentan Clonmel

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-07-04

Application Number :

Regulatory Info : Authorised

Registration Country : Malta

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06

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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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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07

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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Macitentan

Brand Name : Masilva

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 26-08-2024

Application Number :

Regulatory Info :

Registration Country : Moldova

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08

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

Macitentan

Brand Name : Macitentan \"Devatis\"

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 29-07-2025

Application Number : 28107146124

Regulatory Info : Prescription

Registration Country : Denmark

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09

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
Not Confirmed

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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10

Asia Pharma Expo
Not Confirmed
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Asia Pharma Expo
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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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