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01 1ALFRED E TIEFENBACHER GmbH & Co KG

02 1Olpha AS

03 1ACTELION REGISTRATION LTD

04 1Abacus Medicine A/S

05 2Accord Healthcare SLU

06 2Accord Healthcare Slu

07 1Actelion Pharmaceuticals Ltd

08 1Bioglan AB

09 1Clonmel Healthcare Limited

10 1Deva Holding A.?.

11 2Devatis Gmbh

12 1Genepharma SA

13 2Glenmark Arzneimittel Gmbh

14 4Janssen - Cilag International

15 1Janssen-Cilag Ag

16 3Janssen-Cilag International N.V.

17 1Janssen-Cilag International NV

18 10Janssen-Cilag International Nv

19 2Newbury Pharmaceuticals Ab

20 1Norameda Uab

21 1PharmaPath S.A.

22 1Pharmascience International Ltd

23 1Reddy Pharma Iberia Sa

24 1Reig Jofre Laboratory, Sa

25 1STADA Pharmaceuticals AG

26 1Sandoz A/S

27 1Stada Laboratory Sl

28 3Teva Gmbh

29 1medac pharma s.r.l

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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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOlpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

Regulatory Info : Approved

Registration Country : Sweden

Macitentan

Brand Name : Macitentan Olpha

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 02-10-2025

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

Olpha

03

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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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04

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

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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05

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

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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06

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Macitentan

Brand Name : Macitentan Accord

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 24-09-2025

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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07

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Macitentan

Brand Name : Macitentan Accordpharma

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 24-09-2025

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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08

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Macitentan

Brand Name : Macitentan Bioglan

Dosage Form : Film Coated Tablet

Dosage Strength : 10mg

Packaging :

Approval Date : 17-12-2025

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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09

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
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

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

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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