DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 4Alfred E Tiefenbacher GmbH
03 2Medichem S.A
04 2Actavis Inc
05 2Ajanta Pharma Limited
06 2Alkem Laboratories
07 3Alphapharm PTY Ltd
08 7Apotex Inc
09 2Bionpharma
10 2ENDO OPERATIONS
11 3Farm Agon
12 2Hetero Drugs
13 2Indoco Remedies Limited
14 4Inventia Healthcare Limited
15 2Lupin Ltd
16 2MINT PHARMACEUTICALS INC
17 2Macleods Pharmaceuticals Limited
18 2Mankind Pharma
19 2Medley Pharmaceuticals
20 4Nora Pharma
21 2Orchid Pharma
22 1Oyster Point Pharma
23 3Pfizer Consumer Healthcare
24 16Pfizer Inc
25 3Pharmacore Inc
26 2Piramal Pharma Solutions
27 3Sandoz B2B
28 2Teva Pharmaceutical Industries
29 2Viatris
30 2Zydus Lifesciences
01 4Antic-calc Tablet, Film Coated
02 3FILM COATED PILL
03 4Film Coated Tablet
04 2KIT
05 1SPRAY;NASAL
06 5TAB
07 8TABLET
08 2TABLET; ORAL
09 34TABLET;ORAL
10 6Tablet
11 10tablet
12 10Blank
01 2DISCN
02 4EU Dossier Readiness-Q3 2019
03 2Generic EU CTD
04 5Originator
05 31RX
06 45Blank
01 2APO-VARENICLINE
02 2CHANTIX
03 15Champix
04 2Champix 1mg
05 3Champix starter pack
06 2MINT-VARENICLINE
07 4NRA-VARENICLINE
08 3PHARMACOR VARENICLINE
09 1TYRVAYA
10 3VARENAPIX
11 2VARENICLINE
12 32VARENICLINE TARTRATE
13 3Varenicline Sandoz
14 3Varenicline Viatris
15 12Blank
01 15Australia
02 8Canada
03 4Germany
04 6India
05 3Italy
06 6Norway
07 5South Africa
08 2Spain
09 3Sweden
10 37USA
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
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Tablet
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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 : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2024-03-19
Application Number : 213019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2024-03-19
Application Number : 213019
Regulatory Info : RX
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 : 2023-08-23
Application Number : 214557
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-08-23
Application Number : 214557
Regulatory Info : RX
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 : 2023-01-25
Application Number : 201962
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 0.5MG BASE
Packaging :
Approval Date : 2023-10-23
Application Number : 214571
Regulatory Info : RX
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 : 2023-12-04
Application Number : 211862
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : VARENICLINE TARTRATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2023-12-04
Application Number : 211862
Regulatory Info : RX
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 : 2023-08-01
Application Number : 214255
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
Brand Name : TYRVAYA
Dosage Form : SPRAY;NASAL
Dosage Strength : EQ 0.03MG BASE/SPRAY
Packaging :
Approval Date : 2021-10-15
Application Number : 213978
Regulatory Info : RX
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 :
Registration Country : USA
Brand Name : VARENICLINE
Dosage Form : TABLET; ORAL
Dosage Strength : 1MG
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 : 2024-02-28
Application Number : 202019
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
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
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
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