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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 3Farm Agon

13 3G.L. Pharma Gmbh

14 3GSK

15 3Generic Health

16 2Hetero Drugs

17 2Indoco Remedies Limited

18 4Inventia Healthcare Limited

19 4Kern Pharma S.L.

20 4LABORATORIOS NORMON SA

21 2Lupin Ltd

22 4MINT PHARMACEUTICALS INC

23 2Macleods Pharmaceuticals Limited

24 2Medley Pharmaceuticals

25 2NRx Pharmaceuticals

26 4Neuraxpharm

27 3Newbury Pharmaceuticals Ab

28 4Nora Pharma

29 2Orchid Pharma

30 1Oyster Point Pharma

31 2PH HEALTH

32 2PHARMOBEDIENT

33 3Pfizer Consumer Healthcare

34 32Pfizer Inc

35 3Pharmacore Inc

36 2Piramal Pharma Solutions

37 2RHODES PHARMACEUTICALS LP

38 3STADA Arzneimittel

39 3Sandoz B2B

40 2Shilpa Medicare

41 9Teva Pharmaceutical Industries

42 2Viwit Pharmaceuticals Limited

43 3Zentiva

44 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

OTS 2025
Not Confirmed
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OTS 2025
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

OTS 2025
Not Confirmed
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OTS 2025
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

OTS 2025
Not Confirmed
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OTS 2025
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

blank

15

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

VARENICLINE TARTRATE

Brand Name : CHANTIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2006-05-10

Application Number : 21928

Regulatory Info : DISCN

Registration Country : USA

blank

16

OTS 2025
Not Confirmed
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OTS 2025
Not Confirmed

VARENICLINE TARTRATE

Brand Name : CHANTIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2006-05-10

Application Number : 21928

Regulatory Info : DISCN

Registration Country : USA

blank

17

OTS 2025
Not Confirmed
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OTS 2025
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

blank

18

OTS 2025
Not Confirmed
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OTS 2025
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
OTS 2025
Not Confirmed
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PH HEALTH

Country
arrow
OTS 2025
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

blank

20

PH HEALTH

Country
OTS 2025
Not Confirmed
arrow

PH HEALTH

Country
arrow
OTS 2025
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

blank