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01 2Alfred E Tiefenbacher GmbH
02 1NanoAlvand
03 1Abacus Medicine
04 2Accord healthcare
05 1Alembic Pharmaceuticals Limited
06 1Apotex Inc
07 1Aurobindo Pharma Limited
08 1CLONMEL HLTHCARE
09 2Centocor
10 2Deva Holding AS
11 1GSK
12 1Intas Pharmaceuticals
13 15Janssen-Cilag
14 10Johnson & Johnson Innovative Medicine
15 1Laurus Labs
16 1MSN Laboratories
17 1Mirpharm
18 1Newbury Pharmaceuticals Ab
19 1Norameda
20 1PharmaPath S.A.
21 1PharmaScience
22 1Pluviaendo
23 1RHODES PHARMACEUTICALS LP
24 1Reddy Pharma Iberia Sa
25 1Reig Jofre
26 1Seasons Biotechnology
27 1Stada Laboratory Sl
28 1Sun Pharmaceutical Industries Limited
29 1Tecnimede
30 2Teva Pharmaceutical Industries
31 1Torrent Pharmaceuticals Limited
32 1Viatris
33 1Zydus Lifesciences
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01 2Dispersible Tablet
02 1FCT
03 30Film Coated Tablet
04 1Film Coated Tablet
05 4Film-Coated Tablet
06 1Macitentan 10Mg 30 Joined' Oral Use
07 2TABLET
08 12TABLET;ORAL
09 2Tablet
10 6Blank
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01 2Allowed
02 8Approved
03 3Authorised
04 9Authorized
05 5DISCN
06 2EU Dossier Readiness-Q4 2023
07 2Marketed
08 1Originator
09 7Prescription
10 6RX
11 16Blank
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01 1 Masilva
02 1Cidevia
03 1Lyratan
04 11MACITENTAN
05 1Macitentan Accord
06 1Macitentan Accordpharma
07 1Macitentan Clonmel
08 1Macitentan Devatis
09 1Macitentan Dr. Reddy'S
10 1Macitentan Glenmark
11 1Macitentan Newbury
12 1Macitentan Norameda
13 1Macitentan Pharmascience
14 1Macitentan Reig Jofre
15 1Macitentan Stada
16 2Macitentan Teva
17 3OPSUMIT
18 1OPSYNVI
19 13Opsumit
20 2Opsumit®
21 2Opsynvi
22 6Yuvanci
23 1Yuvanci mg
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01 6Australia
02 2Canada
03 5Estonia
04 2Germany
05 1India
06 1Iran
07 1Italy
08 3Malta
09 3Moldova
10 2Norway
11 1Portugal
12 1Russia
13 1South Africa
14 9Spain
15 8Sweden
16 2Switzerland
17 1Turkey
18 12USA
Regulatory Info : EU Dossier Readiness-Q4 2023
Registration Country : Germany
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
Regulatory Info :
Registration Country : Iran
Brand Name : Lyratan
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Regulatory Info : EU Dossier Readiness-Q4 2023
Registration Country : Germany
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
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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info : DISCN
Registration Country : USA
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : India

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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info :
Registration Country : Italy
Brand Name : Opsumit
Dosage Form : Macitentan 10Mg 30 Joined' Oral Use
Dosage Strength : 30 cpr riv 10 mg
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Italy

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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info :
Registration Country : Russia
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Russia

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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey

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Regulatory Info :
Registration Country : USA
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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Regulatory Info : DISCN
Registration Country : USA
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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Regulatory Info : RX
Registration Country : USA
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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Regulatory Info :
Registration Country : Portugal
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal

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Regulatory Info : DISCN
Registration Country : USA
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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Regulatory Info : DISCN
Registration Country : USA
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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Regulatory Info : DISCN
Registration Country : USA
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
