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 1CLONMEL HLTHCARE
07 2Centocor
08 1Deva Holding AS
09 1GSK
10 1Intas Pharmaceuticals
11 8Janssen-Cilag
12 11Johnson & Johnson Innovative Medicine
13 1Laurus Labs
14 1MSN Laboratories
15 1Mirpharm
16 1Newbury Pharmaceuticals Ab
17 1PharmaPath S.A.
18 1PharmaScience
19 1Pluviaendo
20 1RHODES PHARMACEUTICALS LP
21 1Sun Pharmaceutical Industries Limited
22 1Tecnimede
23 1Teva Pharmaceutical Industries
24 1Torrent Pharmaceuticals Limited
25 1Zydus Lifesciences
01 1Antic-calc Tablet, Film Coated
02 1Dispersible Tablet
03 1FCT
04 19Film Coated Tablet
05 1Film Coated Tablet
06 1Macitentan 10Mg 30 Joined' Oral Use
07 2TABLET
08 10TABLET;ORAL
09 2Tablet
10 6Blank
01 2Allowed
02 8Approved
03 3Authorised
04 3Authorized
05 4DISCN
06 2EU Dossier Readiness-Q4 2023
07 1Originator
08 2Prescription
09 5RX
10 14Blank
01 1Cidevia
02 1Lyratan
03 9MACITENTAN
04 1Macitentan Clonmel
05 1Macitentan Devatis
06 1Macitentan Glenmark
07 1Macitentan Newbury
08 1Macitentan Pharmascience
09 1Macitentan Teva
10 3OPSUMIT
11 1OPSYNVI
12 10Opsumit
13 2Opsynvi
14 4Yuvanci
15 1Yuvanci mg
16 6Blank
01 6Australia
02 2Canada
03 2Germany
04 1India
05 1Iran
06 1Italy
07 3Malta
08 1Norway
09 1Portugal
10 1Russia
11 1South Africa
12 3Spain
13 8Sweden
14 2Switzerland
15 1Turkey
16 10USA
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 :
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 : 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
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
