CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

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Pipeline Prospector September 2025: Genmab buys Merus for ~US$ 8 billion, Pfizer buys Metsera to enter obesity race

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Varenicline

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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 20 USDMF, 8 EU WC, 8 KDMF, 14 NDC API, 29 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

34 Drugs in Development

34 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 45 FDA Orange Book, 67 Europe, 12 Canada, 18 Australia, 8 South Africa, 8 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TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 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 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 1 Ingredion Pharma Solutions, 10 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 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, 3 Silverline Chemicals, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives, 24 Fillers, Diluents & Binders, 18 Controlled & Modified Release, 16 Thickeners and Stabilizers, 14 Disintegrants & Superdisintegrants, 11 Direct Compression, 10 Granulation, 10 Lubricants & Glidants, 8 Topical, 7 Film Formers & Plasticizers, 7 Co-Processed Excipients, 5 Empty Capsules, 5 Solubilizers, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids

DIGITAL CONTENT

75 News #PharmaBuzz

75 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 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

5 USP, 19 Others

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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
27/09/2025	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	38693	VARENICLINE TARTRATE	2023-08-30	Active	II	N/A
27/09/2025	Maithri Drugs	India	MAITHRI DRUGS PRIVATE LTD	34174	VARENICLINE TARTRATE	2019-09-30	Active	II	Complete	2020-11-16	2020-09-28

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

52 API Suppliers

20 USDMF

8 EU WC

8 KDMF

14 NDC API

29 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

34 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers

45 FDA Orange Book

67 Europe

12 Canada

18 Australia

8 South Africa

8 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

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 Esteem Industries

1 Finar

7 Gangwal Chemicals

4 Ideal Cures

1 Ingredion Pharma Solutions

10 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

8 Microlex e.U

2 Nitika Pharmaceutical Specialities

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

3 Silverline Chemicals

2 The Dow Chemical Company

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

39 Coating Systems & Additives

24 Fillers, Diluents & Binders

18 Controlled & Modified Release

16 Thickeners and Stabilizers

14 Disintegrants & Superdisintegrants

11 Direct Compression

10 Granulation

10 Lubricants & Glidants

8 Topical

7 Film Formers & Plasticizers

7 Co-Processed Excipients

5 Empty Capsules

5 Solubilizers

5 Rheology Modifiers

4 Vegetarian Capsules

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