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01 2Dr. Reddy's Laboratories

02 4Alfred E Tiefenbacher GmbH

03 2Mankind Pharma

04 3ABEX Pharmaceutica

05 2Actavis Inc

06 2Ajanta Pharma Limited

07 2Alkem Laboratories

08 3Alphapharm PTY Ltd

09 9Apotex Inc

10 2Aurobindo Pharma Limited

11 2Endo International

12 3Farm Agon

13 2Hetero Drugs

14 2Indoco Remedies Limited

15 4Inventia Healthcare Limited

16 2Lupin Ltd

17 2MINT PHARMACEUTICALS INC

18 2Macleods Pharmaceuticals Limited

19 2Medichem S.A

20 2Medley Pharmaceuticals

21 2NRx Pharmaceuticals

22 4Nora Pharma

23 2Orchid Pharma

24 1Oyster Point Pharma

25 3Pfizer Consumer Healthcare

26 16Pfizer Inc

27 3Pharmacore Inc

28 2Piramal Pharma Solutions

29 3Sandoz B2B

30 2Shilpa Medicare

31 2Teva Pharmaceutical Industries

32 2Viatris

33 2Viwit Pharmaceuticals Limited

34 2Zydus Lifesciences

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PharmaCompass

01

  • 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

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

  • 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

04

  • 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

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

  • 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

07

  • 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

08

  • 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

09

Simposio AFI
Not Confirmed
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Simposio AFI
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

blank

10

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
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

11

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
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

12

Simposio AFI
Not Confirmed
arrow
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Simposio AFI
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2023-01-25

Application Number : 201962

Regulatory Info : RX

Registration Country : USA

blank

13

Simposio AFI
Not Confirmed
arrow
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Simposio AFI
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

14

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
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

15

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
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

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
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

Simposio AFI
Not Confirmed
arrow
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Simposio AFI
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

Simposio AFI
Not Confirmed
arrow
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Simposio AFI
Not Confirmed

VARENICLINE

Brand Name : VARENICLINE

Dosage Form : TABLET; ORAL

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number : 201920

Regulatory Info :

Registration Country : USA

blank

19

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 0.5MG BASE

Packaging :

Approval Date : 2024-02-28

Application Number : 202019

Regulatory Info : RX

Registration Country : USA

blank

20

Simposio AFI
Not Confirmed
arrow
arrow
Simposio AFI
Not Confirmed

VARENICLINE TARTRATE

Brand Name : VARENICLINE TARTRATE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Packaging :

Approval Date : 2024-02-28

Application Number : 202019

Regulatory Info : RX

Registration Country : USA

blank