We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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06-09 October, 2025
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Digital content 
CORPORATE CONTENT #SupplierSpotlight
NEWS #PharmaBuzz
08 May 2024
// PRESS RELEASE
02 May 2024
// PRESS RELEASE
09 Apr 2024
// PRESS RELEASE
08 Apr 2024
// PRESS RELEASE
19 Mar 2024
// PRESS RELEASE
29 Feb 2024
// PRESS RELEASE
Drugs in Development
Lead Product(s) : Rivaroxaban,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tiefenbacher Pharmaceuticals Prepares Launch of the Anticoagulant Rivaroxaban
Details : Xarelto-Generic (rivaroxaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is indicated for the treatment of deep vein thrombosis, pulmonary embolism & venous thromboembolism.
Product Name : Xarelto-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 09, 2024
Lead Product(s) : Rivaroxaban,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xarelto-Generic (rivaroxaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is indicated for the treatment of deep vein thrombosis, pulmonary embolism & venous thromboembolism.
Product Name : Xarelto-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 16, 2023
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Aubagio-Generic (teriflunomide) is a USFDA approved pyrimidine synthesis inhibitor which is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Product Name : Aubagio-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 27, 2023
Lead Product(s) : Bilastine,Inapplicable
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Bilastine Tiefenbacher (Bilastine) is a histamine H1 receptor inverse agonist, small molecule drug candidate which is indicated for the treatment of allergic rhino-conjunctivitis & urticaria.
Product Name : Bilastine Tiefenbacher
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 14, 2023
Lead Product(s) : Apremilast,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Otezla-Generic (apremilast) is an inhibitor of phosphodiesterase 4 (PDE4). It is indicated for the treatment of adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers.
Product Name : Otezla-Generic
Product Type : HPAPI
Upfront Cash : Inapplicable
December 01, 2022
Lead Product(s) : Abiraterone Acetate,Prednisolone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Abiraterone and the combination product Abiraterone/Prednisolone are used to treat men with prostate cancer. The 500 mg (mono product) and 500 mg + 5 mg (combination product) tablets will be marketed in Europe by our partners.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 17, 2022
Lead Product(s) : Apixaban,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Apixaban Tiefenbacher (apixaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Product Name : Apixaban Tiefenbacher
Product Type : HPAPI
Upfront Cash : Inapplicable
October 20, 2022
Lead Product(s) : Vildagliptin,Metformin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vildagliptin/Metformin generic version launched in Africa market, the drug ais a diabetes medicine that are used to control the blood glucose (sugar) in adults with type 2 diabetes, by inhibiting DPP-4.
Product Name : Vildagliptin-Metformin-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 08, 2022
Lead Product(s) : Rivaroxaban,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xarelto-Generic (rivaroxaban) is a factor Xa inhibitor, anticoagulant small molecule drug. It is indicated for the treatment of deep vein thrombosis, pulmonary embolism & venous thromboembolism.
Product Name : Xarelto-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 15, 2022
Lead Product(s) : Teriflunomide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Aubagio-Generic (teriflunomide) is a USFDA approved pyrimidine synthesis inhibitor which is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Product Name : Aubagio-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 01, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertralin Tiefenbacher
Dosage Strength : 100mg
Packaging :
Approval Date : 12/12/2003
Application Number : 20031212000155
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertralin Tiefenbacher
Dosage Strength : 50mg
Packaging :
Approval Date : 12/12/2003
Application Number : 20031212000100
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertraparma
Dosage Strength : 100mg
Packaging :
Approval Date : 23/03/2007
Application Number : 20060404000055
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertraparma
Dosage Strength : 50mg
Packaging :
Approval Date : 23/03/2007
Application Number : 20060404000048
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertraxea
Dosage Strength : 100mg
Packaging :
Approval Date : 23/03/2007
Application Number : 20060309000051
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertraxea
Dosage Strength : 50mg
Packaging :
Approval Date : 23/03/2007
Application Number : 20060309000044
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Tifisertral
Dosage Strength : 100mg
Packaging :
Approval Date : 23/03/2007
Application Number : 20060309000075
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Tifisertral
Dosage Strength : 50mg
Packaging :
Approval Date : 23/03/2007
Application Number : 20060309000068
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : LEFLUNOMIDE
Dosage Strength : 10MG
Approval Date : 2021-05-10
Application Number : 213497
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : LEFLUNOMIDE
Dosage Strength : 20MG
Approval Date : 2021-05-10
Application Number : 213497
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Dosage Form : TABLET, DELAYED RELEASE; ORAL
Proprietary Name : POSACONAZOLE
Dosage Strength : 100MG
Approval Date : 2021-02-01
Application Number : 213454
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Europe
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Brand Name : Sertralin Tiefenbacher
Approval Date : 12/12/2003
Application Number : 20031212000155
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Brand Name : Sertralin Tiefenbacher
Approval Date : 12/12/2003
Application Number : 20031212000100
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Brand Name : Sertraparma
Approval Date : 23/03/2007
Application Number : 20060404000055
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Brand Name : Sertraparma
Approval Date : 23/03/2007
Application Number : 20060404000048
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Brand Name : Sertraxea
Approval Date : 23/03/2007
Application Number : 20060309000051
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Brand Name : Sertraxea
Approval Date : 23/03/2007
Application Number : 20060309000044
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Brand Name : Tifisertral
Approval Date : 23/03/2007
Application Number : 20060309000075
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Dosage Strength : 50mg
Packaging :
Brand Name : Tifisertral
Approval Date : 23/03/2007
Application Number : 20060309000068
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : EU Dossier Readiness-Q...
Registration Country : Germany
Dosage Form : Tablet
Dosage Strength : 250MG
Packaging :
Brand Name :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q...
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q...
Registration Country : Germany
Dosage Form : Tablet
Dosage Strength : 500MG
Packaging :
Brand Name :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q...
Registration Country : Germany
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q1 2019
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Status- Under Registration
Registration Country : Germany
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Status- Under Registration
Registration Country : Germany
Regulatory Info : Registered in EU
Registration Country : Germany
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Regulatory Info : Registered in EU
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Regulatory Info : Registered in EU
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Regulatory Info : Registered in EU
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Registered in EU
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q4 2018
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q4 2018
Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q4 2018
Registration Country : Germany
Dosage Form : Tablet
Brand Name :
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Dossier Readiness-Q4 2018
Registration Country : Germany
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Alfred E Tiefenbacher GmbH
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
