Varenicline | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Varenicline
USDMF

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Varenicline

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 20 USDMF, 1 JDMF, 8 EU WC, 7 KDMF, 12 NDC API, 28 Listed Suppliers, $ API Reference Price

41 API Suppliers
20 USDMF
1 JDMF
8 EU WC
7 KDMF
12 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

84 FDF Dossiers, 35 FDA Orange Book, 14 Europe, 6 Canada, 11 Australia, 8 South Africa, 10 Listed Dossiers

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TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Faran Shimi Pharmaceutical, 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, 25 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 Chewable & Orodispersible Aids, 3 Rheology Modifiers, 2 Parenteral

43 Coating Systems & Additives
25 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 Chewable & Orodispersible Aids
3 Rheology Modifiers
2 Parenteral

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 72 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
72 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

14 APIs, 2 FDF Dossiers

14 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) : 45,606 Xls

Filters

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20 All

01 1Dr. Reddy's Laboratories

02 1ALP Pharm

03 1Actavis Inc

04 1Amoli Organics

05 1Apotex Pharmachem

06 1Centaur Pharmaceuticals

07 1Charioteer

08 1Enaltec Labs Private Limited

09 1Hetero Drugs

10 1Jubilant Generics

11 1Lee Pharma

12 1Lupin Ltd

13 1Macleods Pharmaceuticals Limited

14 1Maithri Drugs

15 1Piramal Pharma Solutions

16 1Shilpa Medicare

17 1Unichem Laboratories Limited

18 1Viatris

19 2Viwit Pharmaceuticals Limited

filter Subject Reset all filters

20 All

01 17VARENICLINE TARTRATE

02 1VARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE)

03 1VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]

04 1Varenicline Tartrate

filter Country Reset all filters

20 All

01 1Canada

02 4China

03 12India

04 1Ireland

05 2U.S.A

filter Status Reset all filters

20 All

01 18Active

02 2Inactive

filter GDUFA DMF Review Reset all filters

20 All

01 10Complete

02 10Blank

Seqens Varenicline Tartrate

List of Suppliers

Product Main Page

01

Dr Reddys Laboratories Ltd

Antibody Engineering

Not Confirmed

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

Contact Supplier

Contact Supplier

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

Antibody Engineering

Not Confirmed

02

Actavis Group Ptc Ehf

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Antibody Engineering

Not Confirmed

03

Apotex Pharmachem India Pvt Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Antibody Engineering

Not Confirmed

04

Enaltec Labs Private Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Antibody Engineering

Not Confirmed

05

Jubilant Pharmova Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Antibody Engineering

Not Confirmed

06

Lee Pharma Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : Complete

Rev. Date : 2019-11-12

Pay. Date : 2019-07-24

DMF Number : 33016

Submission : 2018-11-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Lupin Ltd

USDMF

Antibody Engineering

Not Confirmed

07

Lupin Ltd

Antibody Engineering

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

Macleods Pharmaceuticals Ltd

USDMF

Antibody Engineering

Not Confirmed

08

Macleods Pharmaceuticals Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Varenicline Tartrate

GDUFA

DMF Review : Complete

Rev. Date : 2019-11-26

Pay. Date : 2019-10-23

DMF Number : 34096

Submission : 2019-09-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Tianish Laboratories Private Ltd

USDMF

Antibody Engineering

Not Confirmed

09

Tianish Laboratories Private Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Antibody Engineering

Not Confirmed

10

Viwit Pharmaceutical Co Ltd

Antibody Engineering

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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
2

Varenicline Manufacturers | Traders | Suppliers

Varenicline Manufacturers, Traders, Suppliers 1

100

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
Charioteer
Enaltec Labs Private Limited
Hetero Drugs
Jubilant Generics
Lee Pharma
Lupin Ltd
Macleods Pharmaceuticals Limited
Maithri Drugs
Piramal Pharma Solutions
Shilpa Medicare
Unichem Laboratories Limited
Viatris
Viwit Pharmaceuticals Limited

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