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01 2Alfred E Tiefenbacher GmbH

02 1Olpha

03 1NanoAlvand

04 1Abacus Medicine

05 4Accord healthcare

06 1Alembic Pharmaceuticals Limited

07 1Apotex Inc

08 1Aurobindo Pharma Limited

09 1Bioglan

10 1CLONMEL HLTHCARE

11 2Centocor

12 3Deva Holding AS

13 1GSK

14 1Genepharma SA

15 1Glenmark Pharmaceuticals

16 1Intas Pharmaceuticals

17 19Janssen-Cilag

18 10Johnson & Johnson Innovative Medicine

19 1Laurus Labs

20 1MSN Laboratories

21 1Mirpharm

22 2Newbury Pharmaceuticals Ab

23 1Norameda

24 1PharmaPath S.A.

25 1PharmaScience

26 1Pluviaendo

27 1RHODES PHARMACEUTICALS LP

28 1Reddy Pharma Iberia Sa

29 1Reig Jofre

30 1STADA Arzneimittel

31 1Sandoz B2B

32 1Seasons Biotechnology

33 1Stada Laboratory Sl

34 1Sun Pharmaceutical Industries Limited

35 1Tecnimede

36 3Teva Pharmaceutical Industries

37 1Torrent Pharmaceuticals Limited

38 1Viatris

39 1Zydus Lifesciences

40 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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

Regulatory Info :

Registration Country : Iran

Macitentan

Brand Name : Lyratan

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

NanoAlvand

04

  • 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

05

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-08-18

Application Number : 211128

Regulatory Info : RX

Registration Country : USA

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06

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2024-01-09

Application Number : 211195

Regulatory Info : DISCN

Registration Country : USA

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07

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-04-18

Application Number : 211198

Regulatory Info : RX

Registration Country : USA

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08

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Macitentan

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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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 : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2013-10-18

Application Number : 204410

Regulatory Info : RX

Registration Country : USA

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10

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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11

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-11-05

Application Number : 211120

Regulatory Info : RX

Registration Country : USA

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12

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Macitentan

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Russia

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13

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-08-20

Application Number : 211136

Regulatory Info : RX

Registration Country : USA

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14

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 214112

Regulatory Info :

Registration Country : USA

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15

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-12-03

Application Number : 211026

Regulatory Info : DISCN

Registration Country : USA

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16

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-08-26

Application Number : 211123

Regulatory Info : RX

Registration Country : USA

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17

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

Macitentan

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Portugal

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18

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2024-08-05

Application Number : 211107

Regulatory Info : DISCN

Registration Country : USA

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19

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2025-12-03

Application Number : 211161

Regulatory Info : DISCN

Registration Country : USA

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20

International Sweetener Colloquium
Not Confirmed
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International Sweetener Colloquium
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2021-04-06

Application Number : 211224

Regulatory Info : DISCN

Registration Country : USA

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