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01 2Alfred E Tiefenbacher GmbH

02 1NanoAlvand

03 1Apotex Inc

04 1Aurobindo Pharma Limited

05 2Centocor

06 1Intas Pharmaceuticals

07 10Johnson & Johnson Innovative Medicine

08 1MSN Laboratories

09 1Mirpharm

10 1Pluviaendo

11 1RHODES PHARMACEUTICALS LP

12 1Sun Pharmaceutical Industries Limited

13 1Tecnimede

14 1Torrent Pharmaceuticals Limited

15 1Zydus Lifesciences

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PharmaCompass

01

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ASPEN
Not Confirmed
  • 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 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

03

arrow
ASPEN
Not Confirmed
  • 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

04

ASPEN
Not Confirmed
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ASPEN
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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05

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-04-18

Application Number : 211198

Regulatory Info : DISCN

Registration Country : USA

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06

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

MACITENTAN

Brand Name : OPSUMIT

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging : 15/30

Approval Date :

Application Number : 2415690

Regulatory Info :

Registration Country : Canada

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07

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

MACITENTAN

Brand Name : OPSYNVI

Dosage Form : TABLET

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 2521083

Regulatory Info :

Registration Country : Canada

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08

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

macitentan

Brand Name : OPSUMIT

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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11

ASPEN
Not Confirmed
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ASPEN
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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12

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Macitentan

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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13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Macitentanum

Brand Name : Opsumit

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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14

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

macitentan

Brand Name : Opsumit

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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15

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

macitentan

Brand Name : Opsumit

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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16

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

macitentan

Brand Name : Opsumit

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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17

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

macitentan

Brand Name : Opsumit

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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18

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

MACITENTAN

Brand Name : OPSUMIT

Dosage Form : FCT

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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19

ASPEN
Not Confirmed
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ASPEN
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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20

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 211136

Regulatory Info :

Registration Country : USA

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21

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

Macitentan

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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22

ASPEN
Not Confirmed
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ASPEN
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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23

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

MACITENTAN

Brand Name : MACITENTAN

Dosage Form : TABLET; ORAL

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 211123

Regulatory Info :

Registration Country : USA

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24

ASPEN
Not Confirmed
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ASPEN
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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25

ASPEN
Not Confirmed
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ASPEN
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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26

ASPEN
Not Confirmed
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ASPEN
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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