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01 3Orion Corporation

02 2ALFRED E TIEFENBACHER GmbH & Co KG

03 3Aurovitas Spain, Sau

04 3Axunio Pharma GmbH

05 3Cinfa Laboratories Sa

06 6Combix Laboratories Slu

07 3G.L. Pharma Gmbh

08 1Glenmark Arzneimittel GmbH

09 3Glenmark Arzneimittel Gmbh

10 4Kern Pharma Sl

11 3Macleods Pharma Espana Slu

12 3Medichem Sa

13 2Medichem, S.A.

14 4Neuraxpharm Spain Sl

15 3Newbury Pharmaceuticals Ab

16 4Normon Laboratories Sa

17 3PFIZER ITALIA Srl

18 7Pfizer Europe MA EEIG (1)

19 17Pfizer Europe Ma Eeig

20 5Pfizer Limited

21 3Stada Laboratory Sl

22 3Stada Pharmaceuticals Ag

23 7Teva Bv

24 3Viatris Limited

25 6Zentiva Ks

26 2Zentiva ks

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PharmaCompass

01

Varenicline Tartrate

Brand Name : Varenicline Orion

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 30/06/2025

Application Number : 20240402000169

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Varenicline

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

03

Varenicline Tartrate

Brand Name : Varenicline Orion

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg;1mg

Packaging :

Approval Date : 30/06/2025

Application Number : 20240402000183

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner

04

Varenicline Tartrate

Brand Name : Varenicline Orion

Dosage Form : Film Coated Tablet

Dosage Strength :

Packaging :

Approval Date : 30/06/2025

Application Number : 20240402000176

Regulatory Info : Approved

Registration Country : Sweden

Fermion Orion Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Varenicline

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : EU Dossier Readiness-Q3 2019

Registration Country : Germany

Tiefenbacher Compnay Banner

06

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Varenicline

Brand Name : Champix

Dosage Form :

Dosage Strength : 28 Cpr Riv 1 Mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Varenicline

Brand Name : Champix

Dosage Form :

Dosage Strength : 56 Cpr Riv 1 Mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Varenicline

Brand Name : Champix

Dosage Form :

Dosage Strength : 11 Cpr 0.5 Mg + 14 Cpr 1 Mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Varenicline Tartrate

Brand Name : Champix

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg

Packaging :

Approval Date : 26/09/2006

Application Number : 20060927000013

Regulatory Info : Approved

Registration Country : Sweden

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10

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

Varenicline Tartrate

Brand Name : Champix

Dosage Form : Film Coated Tablet

Dosage Strength : 0.5mg;1mg

Packaging :

Approval Date : 26/09/2006

Application Number : 20060105000057

Regulatory Info : Approved

Registration Country : Sweden

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