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List of Drug Master Files (DMF) of Varenicline Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Varenicline
CAS 230615-70-0
USDMF

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Veranova: A CDMO that manages complexity with confidence.

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Varenicline

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 21 USDMF, 1 JDMF, 8 EU WC, 9 KDMF, 11 NDC API, 28 Listed Suppliers, $ API Reference Price

42 API Suppliers
21 USDMF
1 JDMF
8 EU WC
9 KDMF
11 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports

API Reference Price
API Exports
API Imports
FDF Exports

INTERMEDIATES

10 API Suppliers

10 API Suppliers

FINISHED DOSAGE FORMULATIONS

80 FDF Dossiers, 31 FDA Orange Book, 14 Europe, 6 Canada, 11 Australia, 8 South Africa, 10 Listed Dossiers

80 FDF Dossiers
31 FDA Orange Book
14 Europe
6 Canada
11 Australia
8 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 7 Gangwal Healthcare, 1 ACG Worldwide, 3 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 15 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 26 Fillers, Diluents & Binders, 24 Controlled & Modified Release, 16 Direct Compression, 16 Thickeners and Stabilizers, 15 Disintegrants & Superdisintegrants, 11 Lubricants & Glidants, 10 Granulation, 8 Film Formers & Plasticizers, 8 Co-Processed Excipients, 7 Topical, 5 Empty Capsules, 5 Solubilizers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 3 Rheology Modifiers, 3 Chewable & Orodispersible Aids, 2 Parenteral

43 Coating Systems & Additives
26 Fillers, Diluents & Binders
24 Controlled & Modified Release
16 Direct Compression
16 Thickeners and Stabilizers
15 Disintegrants & Superdisintegrants
11 Lubricants & Glidants
10 Granulation
8 Film Formers & Plasticizers
8 Co-Processed Excipients
7 Topical
5 Empty Capsules
5 Solubilizers
4 Vegetarian Capsules
4 API Stability Enhancers
4 Taste Masking
4 Coloring Agents
4 Emulsifying Agents
3 Rheology Modifiers
3 Chewable & Orodispersible Aids
2 Parenteral

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 70 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
70 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Finished Drug Prices, 9 Annual Reports

3 US Medicaid Prescriptions
11 Finished Drug Prices
9 Annual Reports

MARKET PLACE

13 APIs, 2 FDF Dossiers

13 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 1 US Exclusivities, 9 Health Canada Patents

10 US Patents
1 US Exclusivities
9 Health Canada Patents

REF. STANDARDS & IMPURITIES

19 Others

19 Others

$ API Ref.Price (USD/KG) : 52,730 Xls

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21 All

01 1Dr. Reddy's Laboratories

02 1ALP Pharm

03 1Actavis Inc

04 1Amoli Organics

05 1Apotex Pharmachem

06 1Centaur Pharmaceuticals

07 1Enaltec Labs Private Limited

08 1Hetero Drugs

09 1Jubilant Generics

10 2Lee Pharma

11 1Lupin Ltd

12 1Macleods Pharmaceuticals Limited

13 1Maithri Drugs

14 1Piramal Pharma Solutions

15 1Shilpa Medicare

16 1Teva API

17 1Unichem Laboratories Limited

18 1Viatris

19 2Viwit Pharmaceuticals Limited

filter Subject Reset all filters

21 All

01 1VARENICLINE BASE (INTERMEDIATE OF VARENICLINE)

02 16VARENICLINE TARTRATE

03 1VARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE

04 1VARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE)

05 1VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]

06 1Varenicline Tartrate

filter Country Reset all filters

21 All

01 1Canada

02 3China

03 13India

04 1Ireland

05 1Israel

06 2U.S.A

filter Status Reset all filters

21 All

01 19Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

21 All

01 11Complete

02 10Blank

Seqens Varenicline Tartrate

API Suppliers
USDMF
JDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Dr Reddys Laboratories Ltd

CPhI Worldwide, Milan

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38693

Submission : 2023-08-30

Status : Active

Type : II

Dr Reddy Company Banner

Product Web Link

Digital Content

02

Actavis Group Ptc Ehf

USDMF

BioProcess International

Not Confirmed

02

Actavis Group Ptc Ehf

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate Maltodextrin Premix (1:10...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23791

Submission : 2010-05-06

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Apotex Pharmachem India Pvt Ltd

USDMF

BioProcess International

Not Confirmed

03

Apotex Pharmachem India Pvt Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23774

Submission : 2010-05-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

04

Enaltec Labs Private Ltd

USDMF

BioProcess International

Not Confirmed

04

Enaltec Labs Private Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : Complete

Rev. Date : 2018-08-29

Pay. Date : 2018-07-31

DMF Number : 32835

Submission : 2018-06-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Jubilant Pharmova Ltd

USDMF

BioProcess International

Not Confirmed

05

Jubilant Pharmova Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32682

Submission : 2018-03-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Lee Pharma Ltd

USDMF

BioProcess International

Not Confirmed

06

Lee Pharma Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Base (intermediate Of Varenicline)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31576

Submission : 2017-03-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Lupin Ltd

USDMF

BioProcess International

Not Confirmed

07

Lupin Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-15

Pay. Date : 2017-04-27

DMF Number : 31513

Submission : 2017-04-13

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Teva Pharmaceutical Industries Ltd

USDMF

BioProcess International

Not Confirmed

08

Teva Pharmaceutical Industries Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate (as Hpc Solid Solution) D...

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-23

Pay. Date : 2012-11-13

DMF Number : 23708

Submission : 2010-04-12

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Mylan Laboratories Ltd

USDMF

BioProcess International

Not Confirmed

09

Mylan Laboratories Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23441

Submission : 2010-01-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Viwit Pharmaceutical Co Ltd

USDMF

BioProcess International

Not Confirmed

10

Viwit Pharmaceutical Co Ltd

BioProcess International

Not Confirmed

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Digital Content

Varenicline Tartrate (drug Substance, Non-ster...

GDUFA

DMF Review : Complete

Rev. Date : 2018-10-31

Pay. Date : 2018-09-11

DMF Number : 32638

Submission : 2018-02-22

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

1
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Varenicline Manufacturers | Traders | Suppliers

Varenicline Manufacturers, Traders, Suppliers 1

22

We have 19 companies offering Varenicline

Get in contact with the supplier of your choice:

Dr. Reddy's Laboratories
Actavis Inc
ALP Pharm
Amoli Organics
Apotex Pharmachem
Centaur Pharmaceuticals
Enaltec Labs Private Limited
Hetero Drugs
Jubilant Generics
Lee Pharma
Lupin Ltd
Macleods Pharmaceuticals Limited
Maithri Drugs
Piramal Pharma Solutions
Shilpa Medicare
Teva API
Unichem Laboratories Limited
Viatris
Viwit Pharmaceuticals Limited

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