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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 3Deva Holding AS
11 1GSK
12 1Glenmark Pharmaceuticals
13 1Intas Pharmaceuticals
14 19Janssen-Cilag
15 10Johnson & Johnson Innovative Medicine
16 1Laurus Labs
17 1MSN Laboratories
18 1Mirpharm
19 2Newbury Pharmaceuticals Ab
20 1Norameda
21 1PharmaPath S.A.
22 1PharmaScience
23 1Pluviaendo
24 1RHODES PHARMACEUTICALS LP
25 1Reddy Pharma Iberia Sa
26 1Reig Jofre
27 1Seasons Biotechnology
28 1Stada Laboratory Sl
29 1Sun Pharmaceutical Industries Limited
30 1Tecnimede
31 3Teva Pharmaceutical Industries
32 1Torrent Pharmaceuticals Limited
33 1Viatris
34 1Zydus Lifesciences
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01 3Dispersible Tablet
02 1FCT
03 37Film 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 15Prescription
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 1Macitentan "Devatis"
18 1Macitentan "Glenmark"
19 1Macitentan "Newbury"
20 1Macitentan "Teva"
21 3OPSUMIT
22 1OPSYNVI
23 15Opsumit
24 2Opsumit®
25 2Opsynvi
26 8Yuvanci
27 1Yuvanci mg
28 6Blank
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01 6Australia
02 2Canada
03 8Denmark
04 5Estonia
05 2Germany
06 1India
07 1Iran
08 1Italy
09 3Malta
10 3Moldova
11 2Norway
12 1Portugal
13 1Russia
14 1South Africa
15 9Spain
16 8Sweden
17 2Switzerland
18 1Turkey
19 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 :
Application Number :
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
