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01 2Alfred E Tiefenbacher GmbH
02 1NanoAlvand
03 1Alembic Pharmaceuticals Limited
04 1Apotex Inc
05 1Aurobindo Pharma Limited
06 1CLONMEL HLTHCARE
07 2Centocor
08 2Deva Holding AS
09 1GSK
10 1Intas Pharmaceuticals
11 10Janssen-Cilag
12 11Johnson & Johnson Innovative Medicine
13 1Laurus Labs
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17 1PharmaPath S.A.
18 1PharmaScience
19 1Pluviaendo
20 1RHODES PHARMACEUTICALS LP
21 1SEASONS BIOTECH
22 1Sun Pharmaceutical Industries Limited
23 1Tecnimede
24 1Teva Pharmaceutical Industries
25 1Torrent Pharmaceuticals Limited
26 1Viatris
27 1Zydus Lifesciences
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01 1Antic-calc Tablet, Film Coated
02 1Dispersible Tablet
03 1FCT
04 22Film Coated Tablet
05 1Film 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 3Authorized
05 3DISCN
06 2EU Dossier Readiness-Q4 2023
07 1Originator
08 2Prescription
09 8RX
10 17Blank
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01 1 Masilva
02 1Cidevia
03 1Lyratan
04 11MACITENTAN
05 1Macitentan Clonmel
06 1Macitentan Devatis
07 1Macitentan Glenmark
08 1Macitentan Newbury
09 1Macitentan Pharmascience
10 1Macitentan Teva
11 3OPSUMIT
12 1OPSYNVI
13 10Opsumit
14 2Opsumit®
15 2Opsynvi
16 4Yuvanci
17 1Yuvanci mg
18 6Blank
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01 6Australia
02 2Canada
03 2Germany
04 1India
05 1Iran
06 1Italy
07 3Malta
08 3Moldova
09 1Norway
10 1Portugal
11 1Russia
12 1South Africa
13 3Spain
14 8Sweden
15 2Switzerland
16 1Turkey
17 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 :
Registration Country : Norway
Brand Name : Opsumit
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 10 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway

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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 : 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 : 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 : RX
Registration Country : USA
Brand Name : MACITENTAN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2025-12-03
Application Number : 211161
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 : 2021-04-06
Application Number : 211224
Regulatory Info : DISCN
Registration Country : USA

Regulatory Info : RX
Registration Country : USA
Brand Name : MACITENTAN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date : 2025-12-03
Application Number : 211026
Regulatory Info : RX
Registration Country : USA

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