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 3Generic Health
17 2Hetero Drugs
18 2Indoco Remedies Limited
19 4Inventia Healthcare Limited
20 4Kern Pharma S.L.
21 4LABORATORIOS NORMON SA
22 2Lupin Ltd
23 4MINT PHARMACEUTICALS INC
24 2Macleods Pharmaceuticals Limited
25 2Medley Pharmaceuticals
26 2NRx Pharmaceuticals
27 4Neuraxpharm
28 3Newbury Pharmaceuticals Ab
29 4Nora Pharma
30 2Orchid Pharma
31 1Oyster Point Pharma
32 2PH HEALTH
33 2PHARMOBEDIENT
34 3Pfizer Consumer Healthcare
35 32Pfizer Inc
36 3Pharmacore Inc
37 2Piramal Pharma Solutions
38 2RHODES PHARMACEUTICALS LP
39 3STADA Arzneimittel
40 3Sandoz B2B
41 2Shilpa Medicare
42 9Teva Pharmaceutical Industries
43 2Viwit Pharmaceuticals Limited
44 3Zentiva
45 2Zydus Lifesciences
01 4Antic-calc Tablet, Film Coated
02 3FCT
03 47Film Coated Tablet
04 4KIT
05 1SPRAY;NASAL
06 5TAB
07 10TABLET
08 2TABLET; ORAL
09 42TABLET;ORAL
10 19Tablet
11 12tablet
12 11Blank
01 21Approved
02 30Authorized
03 5Cancelled
04 4DISCN
05 4EU Dossier Readiness-Q3 2019
06 3Generic
07 2Generic EU CTD
08 5Originator
09 12Prescription
10 37RX
11 37Blank
01 4APO-VARENICLINE
02 4Byteqi
03 1CABREXXA 0,5
04 2CABREXXA 1
05 2CHANTIX
06 31Champix
07 2Champix 1mg
08 3Champix starter pack
09 3Civarenix
10 3Cuitvar
11 4MINT-VARENICLINE
12 4NRA-VARENICLINE
13 3PHARMACOR VARENICLINE
14 1TYRVAYA
15 3VARENAPIX
16 2VARENICLINE
17 40VARENICLINE TARTRATE
18 4Vareniclina Kern Pharma
19 4Vareniclina Teva
20 2Varenicline
21 3Varenicline Glenmark
22 3Varenicline Lupin
23 3Varenicline Newbury
24 4Varenicline Normon
25 3Varenicline Orion
26 3Varenicline Sandoz
27 3Varenicline Stada
28 3Varenicline Viatris
29 3Varenicline Zentiva
30 10Blank
01 18Australia
02 12Canada
03 4Germany
04 8India
05 3Italy
06 6Norway
07 8South Africa
08 35Spain
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
