We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
01 2Alfred E Tiefenbacher GmbH
02 1NanoAlvand
03 5Actelion Pharmaceuticals Ltd
04 1Apotex Inc
05 1Aurobindo Pharma Limited
06 2Centocor
07 1Intas Pharmaceuticals
08 5Johnson & Johnson Innovative Medicine
09 1MSN Laboratories
10 1Mirpharm
11 1Pluviaendo
12 1RHODES PHARMACEUTICALS LP
13 1Sun Pharmaceutical Industries Limited
14 1Tecnimede
15 1Torrent Pharmaceuticals Limited
16 1Zydus Lifesciences
01 1Antic-calc Tablet, Film Coated
02 1FCT
03 1FILMDRAGERAD TABLETT
04 4Film Coated Tablet
05 1Film Coated Tablet
06 1Filmtabl
07 1Macitentan 10Mg 30 Joined' Oral Use
08 2TABLET
09 1TABLET; ORAL
10 7TABLET;ORAL
11 2Tablet
12 4Blank
01 4DISCN
02 2EU Dossier Readiness-Q4 2023
03 1Originator
04 2Prescription
05 1RX
06 16Blank
01 1Lyratan
02 7MACITENTAN
03 4OPSUMIT
04 1OPSYNVI
05 7Opsumit
06 6Blank
01 4Australia
02 2Canada
03 2Germany
04 1India
05 1Iran
06 1Italy
07 1Norway
08 1Portugal
09 1Russia
10 1South Africa
11 1Sweden
12 1Switzerland
13 1Turkey
14 8USA
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 : 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 : Sweden
Brand Name : OPSUMIT
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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 :
Registration Country : Switzerland
Brand Name : Opsumit
Dosage Form : Filmtabl
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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 : Prescription
Registration Country : Canada
Brand Name : OPSUMIT
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging : 15/30
Approval Date :
Application Number : 2415690
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : OPSYNVI
Dosage Form : TABLET
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 2521083
Regulatory Info : Prescription
Registration Country : Canada
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 : Originator
Registration Country : South Africa
Brand Name : OPSUMIT
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Australia
Brand Name : Opsumit
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Opsumit
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Opsumit
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Opsumit
Dosage Form :
Dosage Strength :
Packaging : 30
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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 :
Registration Country : USA
Brand Name : MACITENTAN
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 211136
Regulatory Info :
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 :
Registration Country : USA
Brand Name : MACITENTAN
Dosage Form : TABLET; ORAL
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number : 211123
Regulatory Info :
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
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