We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
01 2Alfred E Tiefenbacher GmbH
02 1NanoAlvand
03 1Alembic Pharmaceuticals Limited
04 1Apotex Inc
05 1Aurobindo Pharma Limited
06 2Centocor
07 1Deva Holding AS
08 1GSK
09 1Intas Pharmaceuticals
10 8Janssen-Cilag
11 9Johnson & Johnson Innovative Medicine
12 1MSN Laboratories
13 1Mirpharm
14 1Newbury Pharmaceuticals Ab
15 1Pluviaendo
16 1RHODES PHARMACEUTICALS LP
17 1Sun Pharmaceutical Industries Limited
18 1Tecnimede
19 1Teva Pharmaceutical Industries
20 1Torrent Pharmaceuticals Limited
21 1Zydus Lifesciences
01 1Antic-calc Tablet, Film Coated
02 1Dispersible Tablet
03 1FCT
04 16Film Coated Tablet
05 1Film Coated Tablet
06 1Macitentan 10Mg 30 Joined' Oral Use
07 2TABLET
08 9TABLET;ORAL
09 2Tablet
10 4Blank
01 2Allowed
02 8Approved
03 3Authorized
04 4DISCN
05 2EU Dossier Readiness-Q4 2023
06 1Originator
07 2Prescription
08 4RX
09 12Blank
01 1Lyratan
02 8MACITENTAN
03 1Macitentan Devatis
04 1Macitentan Glenmark
05 1Macitentan Newbury
06 1Macitentan Teva
07 3OPSUMIT
08 1OPSYNVI
09 10Opsumit
10 4Yuvanci
11 1Yuvanci mg
12 6Blank
01 4Australia
02 2Canada
03 2Germany
04 1India
05 1Iran
06 1Italy
07 1Norway
08 1Portugal
09 1Russia
10 1South Africa
11 3Spain
12 8Sweden
13 2Switzerland
14 1Turkey
15 9USA
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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 : 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
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Macitentan Devatis
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 03/07/2025
Application Number : 20240314000073
Regulatory Info : Approved
Registration Country : Sweden
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
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
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 :
Application Number :
Regulatory Info :
Registration Country : Italy
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
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Opsumit
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 06/02/2014
Application Number : 61863
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info :
Registration Country : Russia
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Russia
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
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
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
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
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
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
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
