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Varenicline Tartrate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 20 USDMF, 1 JDMF, 8 EU WC, 8 KDMF, 13 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

94 FDF Dossiers, 37 FDA Orange Book, 14 Europe, 10 Canada, 15 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TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 DKSH, 2 Faran Shimi Pharmaceutical, 3 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, 23 Controlled & Modified Release, 23 Fillers, Diluents & Binders, 17 Thickeners and Stabilizers, 14 Disintegrants & Superdisintegrants, 11 Direct Compression, 10 Lubricants & Glidants, 10 Granulation, 8 Film Formers & Plasticizers, 7 Topical, 5 Empty Capsules, 5 Solubilizers, 5 Rheology Modifiers, 5 Co-Processed Excipients, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

72 News #PharmaBuzz

72 News #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Regulatory FDF Prices, 9 Annual Reports

MARKET PLACE

14 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 9 Health Canada Patents

REF. STANDARDS & IMPURITIES

19 Others

19 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	38693	VARENICLINE TARTRATE	2023-08-30	Active	II	N/A
28/03/2025	Actavis Inc	Ireland	ACTAVIS GROUP PTC EHF	23791	VARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]	2010-05-06	Active	II	N/A

Varenicline Tartrate

Varenicline Tartrate

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

41 API Suppliers

20 USDMF

1 JDMF

8 EU WC

8 KDMF

13 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

INTERMEDIATES

10 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

94 FDF Dossiers

37 FDA Orange Book

14 Europe

10 Canada

15 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**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

5 DKSH

2 Faran Shimi Pharmaceutical

3 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

23 Controlled & Modified Release

23 Fillers, Diluents & Binders

17 Thickeners and Stabilizers

14 Disintegrants & Superdisintegrants

11 Direct Compression

10 Lubricants & Glidants

10 Granulation

8 Film Formers & Plasticizers

7 Topical

5 Empty Capsules

5 Solubilizers

5 Rheology Modifiers

5 Co-Processed Excipients

4 Taste Masking

4 Coloring Agents

4 Emulsifying Agents

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