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 2Mankind Pharma
04 2Lee 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 2Endo International
13 3Farm Agon
14 2HANDA PHARMS LLC
15 2Hetero Drugs
16 2Indoco Remedies Limited
17 4Inventia Healthcare Limited
18 2Lupin Ltd
19 4MINT PHARMACEUTICALS INC
20 2Macleods Pharmaceuticals Limited
21 2Medichem S.A
22 2Medley Pharmaceuticals
23 2NRx Pharmaceuticals
24 4Nora Pharma
25 2Norvium
26 2Orchid Pharma
27 1Oyster Point Pharma
28 3Pfizer Consumer Healthcare
29 16Pfizer Inc
30 3Pharmacore Inc
31 2Piramal Pharma Solutions
32 3Sandoz B2B
33 2Shilpa Medicare
34 2Teva Pharmaceutical Industries
35 2Viwit Pharmaceuticals Limited
36 2Zydus Lifesciences
01 4Antic-calc Tablet, Film Coated
02 3FCT
03 3FILM COATED PILL
04 4Film Coated Tablet
05 4KIT
06 1SPRAY;NASAL
07 5TAB
08 10TABLET
09 2TABLET; ORAL
10 42TABLET;ORAL
11 8Tablet
12 10tablet
13 10Blank
01 4DISCN
02 4EU Dossier Readiness-Q3 2019
03 3Generic
04 2Generic EU CTD
05 5Originator
06 37RX
07 51Blank
01 4APO-VARENICLINE
02 1CABREXXA 0,5
03 2CABREXXA 1
04 2CHANTIX
05 15Champix
06 2Champix 1mg
07 3Champix starter pack
08 4MINT-VARENICLINE
09 4NRA-VARENICLINE
10 3PHARMACOR VARENICLINE
11 1TYRVAYA
12 3VARENAPIX
13 2VARENICLINE
14 40VARENICLINE TARTRATE
15 2Varenicline
16 3Varenicline Sandoz
17 3Varenicline Viatris
18 12Blank
01 15Australia
02 12Canada
03 4Germany
04 8India
05 3Italy
06 6Norway
07 8South Africa
08 2Spain
09 3Sweden
10 45USA
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
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 : 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 : 2021-08-11
Application Number : 201785
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 : 2021-08-11
Application Number : 201785
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
