01 3Orion Corporation
02 2Dr. Reddy's Laboratories
03 4Alfred E Tiefenbacher GmbH
04 2Mankind Pharma
05 2Lee Pharma
06 3ABEX Pharmaceutica
07 2Actavis Inc
08 2Ajanta Pharma Limited
09 2Alkem Laboratories
10 3Alphapharm PTY Ltd
11 9Apotex Inc
12 2Aurobindo Pharma Limited
13 3Farm Agon
14 3G.L. Pharma Gmbh
15 3GSK
16 2Hetero Drugs
17 2Indoco Remedies Limited
18 4Inventia Healthcare Limited
19 2Lupin Ltd
20 4MINT PHARMACEUTICALS INC
21 2Macleods Pharmaceuticals Limited
22 2Medichem S.A
23 2Medley Pharmaceuticals
24 2NRx Pharmaceuticals
25 3Newbury Pharmaceuticals Ab
26 4Nora Pharma
27 2Orchid Pharma
28 1Oyster Point Pharma
29 2PH HEALTH
30 2PHARMOBEDIENT
31 3Pfizer Consumer Healthcare
32 16Pfizer Inc
33 3Pharmacore Inc
34 2Piramal Pharma Solutions
35 2RHODES PHARMACEUTICALS LP
36 3STADA Arzneimittel
37 3Sandoz B2B
38 2Shilpa Medicare
39 2Teva Pharmaceutical Industries
40 2Viwit Pharmaceuticals Limited
41 3Zentiva
42 2Zydus Lifesciences
01 4Antic-calc Tablet, Film Coated
02 3FCT
03 25Film Coated Tablet
04 4KIT
05 1SPRAY;NASAL
06 5TAB
07 10TABLET
08 2TABLET; ORAL
09 42TABLET;ORAL
10 8Tablet
11 10tablet
12 10Blank
01 21Approved
02 4DISCN
03 4EU Dossier Readiness-Q3 2019
04 3Generic
05 2Generic EU CTD
06 5Originator
07 37RX
08 48Blank
01 4APO-VARENICLINE
02 1CABREXXA 0,5
03 2CABREXXA 1
04 2CHANTIX
05 15Champix
06 2Champix 1mg
07 3Champix starter pack
08 3Civarenix
09 4MINT-VARENICLINE
10 4NRA-VARENICLINE
11 3PHARMACOR VARENICLINE
12 1TYRVAYA
13 3VARENAPIX
14 2VARENICLINE
15 40VARENICLINE TARTRATE
16 2Varenicline
17 3Varenicline Glenmark
18 3Varenicline Newbury
19 3Varenicline Orion
20 3Varenicline Sandoz
21 3Varenicline Stada
22 3Varenicline Viatris
23 3Varenicline Zentiva
24 12Blank
01 15Australia
02 12Canada
03 4Germany
04 8India
05 3Italy
06 6Norway
07 8South Africa
08 2Spain
09 21Sweden
10 45USA
Regulatory Info : Approved
Registration Country : Sweden
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
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
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Regulatory Info : RX
Registration Country : USA
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
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Regulatory Info :
Registration Country : India
Brand Name : Varenicline
Dosage Form : Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
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
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : EU Dossier Readiness-Q3 2019
Registration Country : Germany
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
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Regulatory Info : RX
Registration Country : USA
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
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Regulatory Info :
Registration Country : India
Brand Name : Varenicline
Dosage Form : Tablet
Dosage Strength : 1.0MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date :
Application Number : 201808
Regulatory Info :
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
Brand Name : VARENICLINE
Dosage Form : TABLET; ORAL
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number : 201920
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
