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01 3Orion Corporation

02 2Dr. Reddy's Laboratories

03 4Alfred E Tiefenbacher GmbH

04 2Mankind Pharma

05 3ABEX Pharmaceutica

06 2Actavis Inc

07 2Ajanta Pharma Limited

08 2Alkem Laboratories

09 3Alphapharm PTY Ltd

10 9Apotex Inc

11 2Aurobindo Pharma Limited

12 3Aurovitas Spain, Sau

13 3Axunio Pharma GmbH

14 3Cinfa Laboratories Sa

15 6Combix Laboratories Slu

16 3G.L. Pharma Gmbh

17 4GSK

18 3Generic Health

19 2Hetero Drugs

20 4Inventia Healthcare Limited

21 2KANCHAN HLTHCARE

22 4Kern Pharma S.L.

23 4LABORATORIOS NORMON SA

24 2Lupin Ltd

25 4MINT PHARMACEUTICALS INC

26 5Macleods Pharmaceuticals Limited

27 5Medichem S.A

28 2Micro Labs Limited

29 2NRx Pharmaceuticals

30 4Neuraxpharm

31 3Newbury Pharmaceuticals Ab

32 4Nora Pharma

33 2Orchid Pharma

34 1Oyster Point Pharma

35 2PH HEALTH

36 2PHARMOBEDIENT

37 39Pfizer Inc

38 3Pharmacore Inc

39 2Piramal Pharma Solutions

40 2REGCON HOLDINGS

41 2RHODES PHARMACEUTICALS LP

42 3STADA Arzneimittel

43 3Sandoz B2B

44 2Shilpa Medicare

45 3Stada Laboratory Sl

46 9Teva Pharmaceutical Industries

47 2Umedica Laboratories

48 3Viatris

49 2Viwit Pharmaceuticals Limited

50 8Zentiva

51 2Zydus Lifesciences

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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 BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2024-10-01

Application Number : 215931

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

03

  • 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

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

Regulatory Info : RX

Registration Country : USA

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2023-08-01

Application Number : 214255

Regulatory Info : RX

Registration Country : USA

Company Banner

05

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

06

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

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2024-10-01

Application Number : 215931

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

08

  • 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

09

  • 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

10

  • 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

11

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

Regulatory Info : RX

Registration Country : USA

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2023-08-01

Application Number : 214255

Regulatory Info : RX

Registration Country : USA

Company Banner

12

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date :

Application Number : 201808

Regulatory Info :

Registration Country : USA

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13

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date :

Application Number : 201808

Regulatory Info :

Registration Country : USA

blank

14

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2023-01-25

Application Number : 201962

Regulatory Info : RX

Registration Country : USA

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15

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : CHANTIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2006-05-10

Application Number : 21928

Regulatory Info : RX

Registration Country : USA

blank

16

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : CHANTIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2006-05-10

Application Number : 21928

Regulatory Info : RX

Registration Country : USA

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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE

Brand Name : VARENICLINE

Dosage Form : TABLET; ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date :

Application Number : 201920

Regulatory Info :

Registration Country : USA

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18

SCOPE Summit
Not Confirmed
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SCOPE Summit
Not Confirmed

VARENICLINE

Brand Name : VARENICLINE

Dosage Form : TABLET; ORAL

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 201920

Regulatory Info :

Registration Country : USA

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19

PH HEALTH

Country
SCOPE Summit
Not Confirmed
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PH HEALTH

Country
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2021-08-11

Application Number : 201785

Regulatory Info : RX

Registration Country : USA

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20

PH HEALTH

Country
SCOPE Summit
Not Confirmed
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PH HEALTH

Country
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SCOPE Summit
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2021-08-11

Application Number : 201785

Regulatory Info : RX

Registration Country : USA

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